From clones to claims: the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Köln ; München [u.a.]
Heymann
2006
|
| Ausgabe: | 4. ed. |
| Schriftenreihe: | Heymanns intellectual property
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XXXVI, 881 S. |
| ISBN: | 3452247384 9783452247384 |
Internformat
MARC
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| 245 | 1 | 0 | |a From clones to claims |b the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice |c by Hans-Rainer Jaenichen ... |
| 250 | |a 4. ed. | ||
| 264 | 1 | |a Köln ; München [u.a.] |b Heymann |c 2006 | |
| 300 | |a XXXVI, 881 S. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 490 | 0 | |a Heymanns intellectual property | |
| 610 | 2 | 4 | |a European Patent Office |
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| 650 | 4 | |a Recht | |
| 650 | 4 | |a Biotechnology |x Law and legislation |z Japan |v Digests | |
| 650 | 4 | |a Biotechnology |x Law and legislation |z United States |v Digests | |
| 650 | 4 | |a Biotechnology |z Europe |v Patents |v Digests | |
| 650 | 0 | 7 | |a Biotechnologie |0 (DE-588)4069491-4 |2 gnd |9 rswk-swf |
| 651 | 4 | |a Europa | |
| 651 | 4 | |a USA | |
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Datensatz im Suchindex
| _version_ | 1804135184998596608 |
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| adam_text | Contents Summary
Page
Preface to the Fourth Edition V
Contributors to the Fourth Edition IX
Contents XIII
1 Patentable Subject Matter: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 1
2 Patentable Subject Matter: The EPO s Case Law 23
3 The Person Skilled in the Art: Legal Basis, Summary and Discussion of the EPO, US and
JPO Practice 49
4 The Person Skilled in the Art: The EPO s Case Law 55
5 Corrections and Amendments: Legal Basis, Summary and Discussion of the EPO, US and
JPO Practice 59
6 Corrections and Amendments: The EPO s Case Law 75
7 Clarity of Claims: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 131
8 Clarity of Claims: The EPO s CaseLaw 139
9 Enabling Disclosure: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 165
10 Enabling Disclosure: The EPO s Case Law 197
11 Deposit: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 295
12 Deposit: The EPO s Case Law 305
13 Priority: Legal Basis, Summary and Discussion ofthe EPO, US and JPO Practice 319
14 Priority: The EPO s Case Law 337
15 Novelty: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 369
16 Novelty: The EPO s Case Law 401
17 Inventive Step: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice .. 505
18 Inventive Step: The EPO s Case Law 541
19 Decisions of the EPO Dealing with Procedural Issues 739
20 Examples of Claims for a European Patent Application 781
21 Examples of Claims for a US Patent Application 783
22 Examples of Claims for a Japanese Patent Application 791
23 How to Draft the Description of a European Patent Application 801
24 How to Draft the Description of a US Patent Application 809
25 How to Draft the Description of a Japanese Patent Application 823
26 How to Keep Notebooks for Successful Interferences 831
Decisions ofthe EPO 837
Decisions on U.S. Cases 855
Decisions on Japanese Cases 867
European Statutes 869
U.S. Statutes 871
Japanese Statutes 873
Index 875
XI
Contents
Page
Preface to the Fourth Edition V
1 Patentable Subject Matter: Legal Basis, Summary and Discussion of the EPO,
US and JPO Practice 1
1.1 Patentable Subject Matter: EPO (Art. 52(1) and (4) and Art. 53 EPC and the EU
Directive of July 6,1998 and its Implementation by the EPO) 1
1.2 Patentable Subject Matter: US (35 U.S.C. § 101 (1984)) 6
1.3 Patentable Subject Matter: JPO 16
2 Patentable Subject Matter: The EPO s Case Law 23
2.1 The Exclusion of Plant and Animal Varieties from Patent Protection in Consideration
of Article 53 EPC 23
2.1.1 Early case law on the exclusion of plant varieties T 49/83, »Propagating material/Ciba
Geigy«, EP A10 588, OJ EPO 1984,112, T 320/87, »Hybrid plants/Lubrizol«,
EP A 4 723, OJ EPO 1990,71 23
2.1.2 A step backwards: T 356/93, »Plant cells/PLANT GENETIC SYSTEMS*, OJ EPO
1995,545 24
2.1.3 An attempt of clarification: G 3/95,»Inadmissible referral*, OJEPO1996,169, and
conclusions 25
2.1.4 Reestablishment of patentability of transgenic plants in general terms: T 1054/96,
»Plants/NOVARTIS« and G 1/98, »Transgenic plant/NOVARTIS II«, OJ EPO
2000, 111 25
2.1.5 T 149/98, »Resistance development/BAYER«, EP B1 408 403 27
2.1.6 T 475/01, »Phosphinotricine resistance gene/BAYER«, EP B1275 957 .... 27
2.1.7 How to apply Article 53 EPC in the patenting of transgenic animals: the pioneering
decisions T 19/90, »Onco mouse/HARVARD«, EP A 169 672, OJ EPO 1990,476,
and T 315/03, »Transgenic animals/HARVARD« 28
2.2 The Exclusion of »Essentially Biological Processes for the Production of Plants« from
Patent Protection: T 320/87, »Hybrid plants/Lubrizok, EP A 4 723,
OJEPO 1990,71 34
2.3 The Exclusion of »Essentially Biological Processes for the Production of Animals«
from Patent Protection: T 19/90, »Onco mouse/HARVARD«, EP A 169 672,
OJ EPO 1990,476 35
2.4 The Patenting of Human DNA is not Intrinsically Unethical: Opposition Division,
»Relaxin«, EP B1112 149, OJ EPO 1995,388, and T 272/95, »Relaxin/HOWARD
FLOREY INSTITUTE* 35
2.5 Compounds and Discoveries 36
2.5.1 DNA Sequences Isolated from Natural Sources Are no Discovery: Opposition Divi¬
sion, »Relaxin«, EP B1112 149, OJEPO 1995,388, andT 272/95, »Relaxin/
HOWARD FLOREYINSTITUTE« 36
2.5.2 Recombinant heterodimeric receptors are no discovery when industrially applicable:
T 338/00, »Multimeric receptors/SALK INSTITUTE*, EP B1 619 842 37
2.6 The Patenting of Pharmaceutical Inventions 38
XIII
Contents
2.7 The Patenting of Diagnostic Inventions and Screening Methods 43
2.7.1 T 1038/00, »Apoptotic cells/NEXINS RESEARCH*, EP B1 755 516 43
2.7.2 T 310/99, »Down Syndrome/MACRI«, EP B1409 956 43
2.8 Supplementary Protection Certificates (SPCs) for Pharmaceuticals and Plant
Protection Products 44
2.8.1 Introduction 44
2.8.2 Conditions for Obtaining a Certificate 44
2.8.3 Deadline for Applications 45
2.8.4 Documentation Required 45
2.8.5 Duration of the SPC 45
2.8.6 Problems regarding Licenses 45
2.8.7 The Scope of Protection of an SPC 46
3 The Person Skilled in the Art: Legal Basis, Summary and Discussion of the EPO,
US and JPO Practice 49
3.1 The Person Skilled in the Art: EPO 49
3.2 The Person Skilled in the Art: US 50
3.3 The Person Skilled in the Art: JPO 52
4 The Person Skilled in the Art: The EPO s Case Law 55
5 Corrections and Amendments: Legal Basis, Summary and Discussion of the EPO,
US and JPO Practice 59
5.1 Corrections and Amendments: EPO (Art. 123 and Rule 88 EPC) 59
5.2 Corrections and Amendments: US 64
5.3 Corrections and Amendments: JPO 68
6 Corrections and Amendments: The EPO s Case Law 75
6.1 T 184/91, »Glu Gln/CELTRIX«, EP A169 016, G 11/91, »Glu Gln/CELTRIX«,
EP A169 016; andT 1147/98, »Cartilage inducing factor/CELTRIX PHARMA¬
CEUTICALS INC.«,EP B1169016 75
6.2 T 161/86, »Amino acid sequence modification/ELI LILLY«, EP A 10 421 77
6.3 T 552/91, »Chroman derivatives/MERCK«, EP A 273 262 78
6.4 T 21/86, »Amendments/AMERICAN MONITOR CORP.«, EP A 9 222 79
6.5 T 365/88 improved vectors/BIOGEN«, EP A 41 767 79
6.6 T 449/90, »Treatment of plasma/CEDARS SINAI«, EP B 94 611 80
6.7 T 157/90, »Human calcitonin structural gene/CELL TECH«, EP A 70 675 81
6.8 T 923/92, »t PA/GENENTECH«, EP B193 619, OJ EPO 1996,564 83
6.9 T 749/94, »Erythropoietin/GENETICS INSTITUTE*, EP B1 209 539 86
6.10 T 379/95, »Hormones/ARS«, EP B1160 699 87
6.11 T 1046/96, »Pertussis/LELAND STANFORD*, EP B1275 689 88
6.12 T 277/95, »Production of erythropoietin/GENETICS INSTITUTE*,
EP B1 411 678 89
6.13 T 656/94, »Colony stimulatingfactor/KIRIN AMGEN«, EP B1 237 545 90
6.14 T 824/94, »LAV/INSTITUT PASTEUR«, EP B1178 978 90
6.15 T 138/95, »Intrapulmonary delivery/GENENTECH INC.«, EP B1257 956 92
6.16 T 985/95, »Treatment of infertility/NOVO NORDISK A/S«, EP B1 300 021 92
6.17 T 289/97, »Brassica/CALGENE«, EP B1270 615 93
6.18 T 354/97, »Protein secretion/GENENTECH*, EP B1 88 632 94
6.19 T 658/98, »Interferon beta 2A/YEDA RESEARCH*, EP A 645 542 95
XIV
Contents
6.20 T 588/95, »Chimera monoclonal antibody/RESEARCH DEVELOPMENT*,
EP B1171 496 96
6.21 T 188/97, »NANBV/Chiron Corporation*, EP B1318 216 96
6.22 T 1054/97, »Insect control/AVENTIS«, EP B1451 878 98
6.23 T 32/97, »Deleted tk PRV vaccines/NOVAGENE«, EP B1149 040 99
6.24 T 339/98, »Vitamin K dependent proteins/ELI LILLY«, EP B1 363 126 99
6.25 T 725/99, »Live vaccines/LELAND STANFORD JUNIOR UNIVERSITY*,
EP B1184 086 100
6.26 T 351/98, »HIV I/CHIRON CORPORATION*, EP B1181150 101
6.27 T 239/95, »Herpes simplex viral proteins/AMERICAN CYANAMID CO.«,
EP B1101 655 102
6.28 T 450/98, »BPI fragments/NEW YORK UNIVERSITY*, EP B1 375 724 ......... 103
6.29 T 93/98, »TNF inhibiting protein/BASF«, EP B1 471 701 103
6.30 T 1118/98,»Nucleicacids/DUPONTDENEMOURS«,EP B1520039 104
6.31 T 160/99, »Chlamydia/WASHINGTON«, EP Bl264 434 105
6.32 T 232/99, »Proteinproduction/ALUSUISSE HOLDINGS A.G.«,EP B1239 292 . 105
6.33 T 756/00, »Immunotherapy/CENTOCOR INC.«, EP A 755 683 106
6.34 T 346/01, »Osteoporosis/NOVARTIS«, EP A 560 723 106
6.35 T 216/96, »Process for amplifying, detecting and/or cloning nucleic acid sequences/
F. HOFFMANN LA ROCHE AG«, EP B1200 362 107
6.36 T 785/97, »Support bound oligonucleotides/OXFORD GENE TECHNOLOGY
LIMITED*, EP B1 386229 107
6.37 T 310/99, »Down Syndrome/MACRI«, EP B1409 956 108
6.38 T 944/99,»Pesticidaltoxins/MYCOGENCORPORATION*,EP B1 340948 .... 109
6.39 T 279/00,»Asymmetric reductionprocess/AVECIA LTD.*, EP B1 658 211 109
6.40 T 502/00, »Determination of an analyte/DADE«, EP B1 492 499 110
6.41 T 608/00,»Transgenicbovine/PHARMING*,EP B1 502976 110
6.42 T 748/00, »Oligomer libraries/AFFYMAX*, EP B 1 604 552 Ill
6.43 T 1000/00, »Test device/ROCHE*, EP B1 654 659 112
6.44 T 1228/01, »Zona pelucida antigens/ZONAGEN INC.*, EP A 396 552 112
6.45 T 86/01, »Engineered bacteriophages/ACAMBIS*, EP B1 552 267 114
6.46 T 98/01, »Allergenicproteins/IMMULOGIC PHARMACEUTICAL
CORPORATION*, EP B1463 059 115
6.47 T 189/01, »IFN P2/IL 6R/YEDA RESEARCH AND DEVELOPMENT CO.,
LTD.«, EP B1413 908 115
6.48 T 1133/00, »Tumor suppression/UNIVERSITY OF CALIFORNIA*,
EP B1 475 623 116
6.49 T 286/01, »Humanised antibodies/CELLTECH THERAPEUTICS LTD.«,
EP B1460 167 116
6.50 T 345/01, »Cellulose degrading enzyme/NOVOZYMES«, EP B1 531 315 117
6.51 T 836/01, »Interferon beta2/YEDA RESEARCH AND DEVELOPMENT CO.
LTD.«, EP A 835 661 117
6.52 T 882/01 ; »Protein expressionsystem/CELLTECH«, EP Bl 651 803 117
6.53 T 1014/01, »Recombinant immunoconjugates/BRISTOL MYERS SQUIBB CO.«,
EP Bl 439 095 118
6.54 T 1100/01, »Truncated transmembrane PACE/GENETICS«, EP Bl 574 402 119
6.55 T 1080/01, »Thermostableenzyme/F. HOFFMANN LA ROCHE*, EP Bl 258017 119
6.56 T 161/02, »Transgenic Zea mays plants/SYNGENTA«, EP Bl 513 849 120
6.57 T 579/01, »Cytoplasmic male sterile plants/ENZA ZADEN«, EP Bl 771 523 121
6.58 T 960/02, »Transfection/TRANSKARYOTIC THERAPIES*, EP Bl 649 464 122
6.59 T 1067/02, »Changed epitopes/NOVOZYMES«, EP Bl 561 907 123
6.60 T 157/03, »Reducing blood loss/ZYMOGENETICS«, EP Bl 624 095 124
6.61 T 1050/99, »Carbonyl hydrolases/GENENCOR«, EP Bl 251 446 125
XV
Contents
6.62 T 931/01, »Ribozyme/UNIVERSITY PATENTS*, EP B1291533 126
6.63 T 877/03, »Anti CD30 antibodies/ROCHE«, EP B1 805 871 126
6.64 T 626/00, »Framework mutated antibodies/WELLCOME«, EP B1 549 581 127
6.65 T 27/04, »Japanese hepatitis C virus/CHIRON«, EP B1419 182 129
6.66 T 20/04, »Flt3 ligands/SCHERING«, EP B1 699 236 129
6.67 T 1331/04, »MSF/GENETICS INSTITUTE*, EP A 567 599 130
7 Clarity of Claims: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 131
7.1 Clarity of Claims: EPO (Art. 84 EPC) 131
7.2 Clarity of Claims: US 134
7.3 Clarity of Claims: JPO 137
8 Clarity of Claims: The EPO s Case Law 139
8.1 T 301/87, »Alpha imerferons/BIOGEN«, EP B 32134, OJ EPO 1990,335 139
8.2 T 281/86, »Preprothaumatin/UNILEVER«, EP A 54 331, OJ EPO 1989,202 141
8.3 T 181/87, »DNA transfer vector/THE REGENTS OFTHE UNIVERSITY OF
CALIFORNIA*, EP A20 251 141
8.4 T 269/87, »Prochymosin/CELLTECH«, EP A 68 691 142
8.5 T 347/87, »Method of constructing a replicable cloning vehicle/GENENTECH«,
EP A22242 143
8.6 T 130/90 »Recombinant Monoclonal Antibody/UNIVERSITY OF TEXAS
SYSTEM*, EP B 68 763 144
8.7 T 391/91, »Ice nucleating/UNIVERSITY OF CALIFORNIA*, EP A 112 342 145
8.8 T 430/92, »Growthof tulips/SUMITOMO«,EP Bl 188 933 147
8.9 T 749/94, »Erythropoietin/GENETICS INSTITUTE*, EP B 1209 539 147
8.10 T 464/94, transformation of plant genetic material/NOVARTIS«, EP B1164 575 . 148
8.11 T 250/96, »Transformation/NOVARTIS«, EP A1429 093 149
8.12 T 277/95, »Production of erythropoietin/GENETICS INSTITUTE*,
EP B1 411 678 150
8.13 T 484/98, »Modified yeast/ELSWORTH«, EP A 463 024 150
8.14 T 965/98, »DNA amplification/HOFFMANN LA ROCHE«, EP A 509 612 151
8.15 T 966/98, »DNA detection/HOFFMANN LA ROCHE*, EP A 502 589 152
8.16 T 188/97, »NANBV/Chiron Corporation*, EP Bl 318 216 152
8.17 »Serotonin receptor/ELI LILLY*, EP A 449 562, OJ EPO 2001,103 153
8.18 T 1044/99, »Ionophoreantibiotics/UNGDA«,EP 615 544 153
8.19 T 680/98, improved vectors II/BIOGEN*, EP Bl 41 767 153
8.20 T 822/98, »Probes/BIO RAD«, EP Bl 246 864 154
8.21 T 239/95, »Herpes simplex viral proteins/AMERICAN CYANAMID CO.«,
EP Bl 101 655 155
8.22 T 64/00, »Insecticidal plant expression/MYCOGEN*, EP Bl 359 472 156
8.23 T 984/00, »Ti plasmid vectors/MAX PLANCK GESELLSCHAFT«,
EP A 290 799 157
8.24 T 1084/00, »HIV 3 variants/INNOGENETlCS*, EP Al 657 532 158
8.25 T 397/02, »Endogenous gene expression/APPLIED RESEARCH SYS«,
EP B 505 500 159
8.26 T 285/01, »Bone resorption/WASHINGTON RESEARCH FOUNDATION*,
EP Bl 394296 160
8.27 T 610/01, »Plant growth/LONG ASHTON RESEARCH STATION*,
EP A 703 983 160
8.28 T 347/02, »Neoplastic phenotype/UNIVERSITY OF CALIFORNIA*,
EP Bl 440 744 161
XVI
I Contents
] 8.29 T 1074/00, »Hematopoietic growth factors/GENETICS INSTITUTE*,
EP B1314 705 161
9 Enabling Disclosure: Legal Basis, Summary and Discussion of the EPO, US and
JPO Practice 165
9.1 Enabling Disclosure: EPO (Art. 83 EPC) 165
9.2 Enabling Disclosure: US 173
9.3 Enabling Disclosure: JPO 189
10 Enabling Disclosure: TheEPO s Case Law 197
10.1 Decisions on enablement of nucleic acid and protein inventions 197
10.1.1 The Genentech polypeptide expression cases T 292/85 and T 794/94, EP B1 1 929 . 197
10.1.2 T 293/85, »Hybrid polypeptides/GENENTECH II«, EP A1 930 201
10.1.3 T 347/87, »Method of constructing a replicable cloning vehicle/GENENTECH«,
EP A 22 242 201
10.1.4 T 301/87, »Alpha interferons/BIOGEN«, EP B 32 134 202
10.1.5 T 281/86, »Preprothaumatin/UNILEVER«, EP A 54 331 202
! 10.1.6 T 283/86, »Bovinepre growthhormone/THE REGENTS OF THE UNIVERSITY
; OF CALIFORNIA*, EP A 47 600 203
i 10.1.7 Tl81/87,»DNAtransfervector/THEREGENTSOFTHEUNIVERSITYOF
CALIFORNIA*, EP A 20 251 204
10.1.8 T 772/89, »Bovine growth hormone/CASE WESTERN RESERVE
UNIVERSITY*, EP A 112 012 204
10.1.9 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 205
10.1.10 T 923/92, »t PA/GENENTECH«, EP B 193 619 • 210
10.1.11 T 128/92, »Interleukin 2/AJINOMOTO«, EP Bl 0 091 539 211
10.1.12 T 918/94, »Calcitonin/CELLTECH«, EP A 70 675 212
10.1.13 T 639/95, »Biopolymers/MIT«, EP A 329 770 213
10.1.14 T27/93,»Humannervegrowthfactor/GENENTECH«,EP B1121338 215
10.1.15 T 277/95, »Production of erythropoietin/GENETICS INSTITUTE*,
EP Bl 411 678 215
10.1.16 T 656/94, »Colony stimulating factor/KIRIN AMGEN«, EP Bl 237 545 216
10.1.17 T 493/94, »CSF/CHUGAI«, EP Bl 169 566 217
10.1.18 T 994/95, »01igonucleotide therapeutic agent/MOLECULAR BIOSYSTEMS*,
EP Bl 92 574 218
10.1.19 T 236/96, »Interleukin 1/DAINIPPON«, EP Bl 188 920 219
10.1.20 T 746/94, »Polypeptide isolation/BERLEX*, EP Bl 183 776 219
10.1.21 T 915/94, »Carbonyl hydrolases/GENENCOR INTERNATIONAL INC.«,
EP Bl 130 756 219
10.1.22 T 354/97, »Protein secretion/GENENTECH*, EP Bl 88 632 220
10.1.23 T 743/97,»Thrombolyticproteins/GENETICSINSTITUTE*,EP Bl293394 .... 220
10.1.24 T 1055/97, »Drug delivery conjugates/EN2O«, EP Bl 285 950 221
10.1.25 T 838/97, »Translationalinhibition/RESEARCH FOUNDATION*,
EP Bl 140 308 222
10.1.26 T 749/98, »Cellulase/NOVOZYMES A/S«, EP Bl 531 372 ._ 223
101.27 T216/96, »Process for amplifying, detecting and/or cloning nucleic acid sequences/
F. HOFFMANN LA ROCHE AG«, EP Bl 200 362 224
10.1.28 T 280/00, »Inhibin/GENENTECH«, EP Bl 222 491 226
10.1.29 T 620/99, »Homologous recombination/CELL GENESIS INC.«, EP Bl 452 484 .. 227
10.1.30 T 58/00, »Hepatic growth factor/MITSUBISHI«, EP Bl 412 557 228
10.1.31 T 15/00, »Serum albumin/DELTA BIOTECH*, EP Bl 386 222 229
10.1.32 T 731/00, »Cleansingproteins/OCTAPHARMA«, EP Bl 484 464 230
XVII
Contents
10.1.33 T 748/00, »Oligomer libraries/AFFYMAX«, EP B1 604 552 231
10.1.34 T 787/00, »Erythropoietin/AMGEN«, EP B1428 267 231
10.1.35 T 397/02, »Endogenous gene expression/APPLIED RESEARCH SYS«,
EP B 505 500 234
10.1.36 T 351/01, »Tissue factor protein/GENENTECH«,EP Bl 278 776 235
10.1.37 T 811/01, »IL 1 inhibitor/BIOGEN«, EP B1341273 236
10.1.38 T 1120/01, »Cell surface antigen/OSAKA BIOSCIENCE«; EP A 510 691 237
10.1.39 T 1080/01, »Thermostableenzyme/F. HOFFMANN LA ROCHE«,EP B1258 017 237
10.1.40 T 1074/00, »Hematopoietic growth factors/GENETICS INSTITUTE*,
EP B1 314 705 238
10.1.41 T 1067/02, »Changed epitopes/NOVOZYMES«, EP B1 561 907 239
10.1.42 T 1093/02, »Nucleic acids probes/GEN PROBE INC.«, EP A 272 009 240
10.1.43 T 558/03, Wild type p53 gene/JOHNS HOPKINS UNIVERSITY*, EP B 1390323 241
10.2 Decisions on enablement of antibody technology inventions 241
10.2.1 T 299/86, »Monoclonal anti ot IFN antibody/SECHER«, EP A 50 129, OJ EPO
1988,88 241
10.2.2 Examining Division, »Deposit number/ROCKEFELLER«, EP 86 90 2639.3 242
10.2.3 The Ortho monoclonal antibody cases 243
10.2.4 T 431/96, »Monoclonal antibody/AGEN«, EP B1122 478 246
10.2.5 T 669/97, »Chimeric antibodies/CELLTECH THERAPEUTICS LTD«,
EP B1194 276 247
10.2.6 T 400/97, »Immunoglobulins/CELLTECH«, EP B1120 694 248
10.2.7 T 1212/97, »Immunoglobulin preparations/GENENTECH«, EP B1125 023 250
10.2.8 T 310/99, »Down Syndrome/MACRI«, EP B1409 956 250
10.2.9 T 505/00, »Anti free PSA antibody/LILJA«, EP B1 540 573 251
10.2.10 T 792/00, »Varied binding proteins/DYAX«, EP B1 436 597 252
10.2.11 T 619/01, »Immunotoxins/RESEARCH DEVELOPMENT FOUNDATION«,
EP A1 634 938 253
10.2.12 T 877/03, »Anti CD30 antibodies/ROCHE«, EP B1 805 871 253
10.2.13 T 626/00, »Framework mutated antibodies/WELLCOME«, EP B1 549 581 254
10.3 Decisions on enablement of plant inventions 255
10.3.1 T 612/92, »Monocotyledonous plants/RIJKSUNIVERSITEIT LEIDEN«,
EP B1159 418 255
10.3.2 T 694/92, »Modifyingplant cells/MYCOGEN«, EP B1122 791 256
10.3.3 T 1052/98, »Gene switch/SYNGENTA«, EP A 455 667 258
10.3.4 T 149/98, »Resistance development/Bayer«, EP B1 408 403 258
10.3.5 T 984/00, »Ti plasmid vectors/MAX PLANCK GESELLSCHAFT«,
EP A 290 799 259
10.3.6 T 78/01, »Insect resistant plants/MYCOGEN«, EP B1142 924 259
10.3.7 T 1120/00, »Soybean desaturase/DU PONT«, EP B1 537178 260
10.3.8 T 610/01, »Plant growth/LONG ASHTON RESEARCH STATION*,
EP A 703 983 261
10.3.9 T 891/02, »Potatostarch/BASF«, EP A 563 201 261
10.3.10 T 579/01, »Cytoplasmic male sterile plants/ENZA 2ADEN«, EP B1 771 523 261
10.3.11 T 1006/02, »Selection of transformed cells/SYNGENTA«, EP B1 601 092 262
10.3.12 T 550/03, »Epigenetic regulation/STERNHEIMER«, EP A 648 275 262
10.4 Decisions on enablement of inventions concerning viruses and their epitopes 263
10.4.1 T 449/90, »Treatment of plasma/CEDARS SINAI«, EP B 94 611 263
10.4.2 T 886/91, »Hepatitis B virus/BIOGEN«, EP B113 828 264
10.4.3 T 187/93, »Vaccines/GENENTECH«, EP B1139 417 265
10.4.4 T 824/94, »LAV/INSTITUT PASTEUR«, EP B1178 978 266
10.4.5 T 188/97, »NANBV/Chiron Corporation*, EP B1 318 216 267
10.4.6 T 32/97, »Deleted tk PRV vaccines/NOVAGENE«, EP B1149 040 269
XVIII
, Contents
10.4.7 T 351/98, »HIV I/CHIRON CORPORATION*, EP B1181150 270
10.4.8 T 239/95, »Herpes simplex viral proteins/AMERICAN CYANAMID CO.«,
EP B1101655 271
/ 10.4.9 T 552/00, »3D MPL/SMITHKLINE«, EP B1 689 454 : . 272
10.4.10 T 839/01, »Non A/non B hepatitis virus/GENELABS TECHNOLOGIES*,
EP A419 576 272
10.4.11 T 857/01, »Herpes simplex virus/GENERAL HOSPITAL*, EP B1 453 242 273
10.4.12 T 127/02,»Herpesvirusmutantsstromalkeratitis/HARVARD«,EP A739414 .... 273
10.4.13 T 15/01, »Mystery swine disease/SDLO«, EP Bl 587 780 .¦ 274
10.5 Decisions on enablement of inventions concerning microorganisms 275
10.5.1 T 740/90, »Active dry yeast/LESAFFRE«, EP B 8 554 ....; 275
10.5.2 T 48/85, »Coccidiosis vaccines/NRDC«, EP A 47 662 276
10.5.3 T 242/92, »Invasivephenotype/STANFORD«, EP A211 543 278
10.5.4 T 780/95, »Antigenicpreparations/EVANSMEDICAL«, EP Bl 162 639 279
10.5.5 T 727/95, »Cellulose/WEYERSHAEUSER«, EP Bl 228 779 280
10.5.6 T 446/99, »Bordetella toxin/AMGEN«, EP Bl 306 318 282
10.5.7 T 36/00, »Proteinase deficient fungi/GENENCOR*, EP Bl 429 490 282
10.6 Decisions on enablement of other inventions 283
10.6.1 T 19/90, »Onco mouse/HARVARD«, EP A 169 672 283
10.6.2 T 383/94, »Aminooxydase/UNDERBERG«, EP Bl 170 880 284
10.6.3 T 289/96, »Detecting sequences/ZENECA«, EP Bl 332 435 284
10.6.4 T 985/95, »Treatment of infertility/NOVO NORDISK A/S«, EP Bl 300 021 ...... 285
10.6.5 T 455/96, »Blood substitute/BIOPURE CORPORATION*, EP Bl 277289 285
10.6.6 T 148/98, »Blood substitutes/BAXTER BIOTECH TECHNOLOGY*,
EP Bl 358 708 285
10.6.7 T 944/99, »Pesticidal toxins/MYCOGEN CORPORATION*, EP Bl 340 948 .... 286
10.6.8 T 222/00, »Hemicellulose degradation/VALTION«, EP B 1 545 958 286
10.6.9 T 285/01, »Bone resorption/WASHINGTON RESEARCH FOUNDATION*,
EP Bl 394 296 287
10.6.10 T 537/02, »Detergent composition/UNILEVER*, EP Bl 563 103 287
10.6.11 T 609/02, »AP 1 complex/SALK INSTITUTE*, EP Bl 552 202 288
10.6.12 T 716/01, »Bone resorption/WASHINGTON RESEARCH FOUNDATION*,
EP Bl 502 928 290
10.6.13 T 1127/02, »Soluble and insoluble form of an antigen/CONNAUGHT*,
EP Bl 588 578 291
10.6.14 T 157/03, »Reducing blood loss/2YMOGENETICS«, EP Bl 624 095 291
10.6.15 T 729/00, »Screeningmethod/HOUSEY*, EP Bl 403 506 292
10.6.16 T 669/04, »CED 3 inhibitors/MIT«, EP A 672151 293
11 Deposit: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 295
11.1 Deposit: EPO (Art. 83 EPC and Rule 28 of the Implementing Regulations) 295
11.2 Deposit: US 298
11.3 Deposit: JPO 301
12 Deposit: The EPO s Case Law 305
12.1 T 361/87, »Microorganisms/NABISCO«, EP A 97 973 305
12.2 T 39/88, »Microorganisms/CPC«, EP A 111 683 305
12.3 T 106/88, »Microorganisms/CPC«, EP A 112 459; T 90/88, »Microorganism/
MICROLIFE*, EP A 76 953; T 239/87, »Microorganisms/NABISCO«,
EP A 98 533; T 142/93, »Antibiotics/AMERICAN CYANAMID*, EP A 182152 . 306
12.4 T 118/87, »Amylolytic enzymes/CPC«, EP A 34 470 306
12.5 J 8/87J 9/87, »Submitting culture deposit information/IDAHO«, EP A 155 476 .. 307
XIX
Contents
12.6 Examining Division, »Deposit number/ROCKEFELLER«, EP 86 90 2639.3 307
12.7 T 815/90, »Hepatitis Avirus/UMTED STATES OF AMERICA*, EP A196 316,
G 2/93, »Sufficiency of disclo sure/Culture deposit information 308
12.8 T 886/91, »Hepatitis B virus/BIOGEN«, EP B113 828 311
12.9 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 311
12.10 T 923/92, »t PA/GENENTECH«, EP B163 619 312
12.11 T 128/92, »Interleukin 2/AJINOMOTO«, EP B1 0 091 539 313
12.12 T 227/97, »Protein Rib/LINDAHL«, EP A 656 014 313
12.13 T 1147/01, »PRRS Vaccine/AKZO NOBEL N.V.«, EP B1 610 250 313
12.14 Questions and Answers Addressing Some Practical Problems of Deposits for
European Patent Applications and PCT Applications Designating the EPO 314
12.14.1 Does Rule 28(2) of the Implementing Regulations require submission of information
in a specific form? 314
12.14.2 Can availability of the deposited microorganism to third parties be terminated by
deleting deposit information from the published PCT application when it is moved to
the EP stage? 314
12.14.3 How are the limitations under Rule 28(3) influenced by refusal or withdrawal of an
application or expiration of a patent term? 315
12.14.4 What penalties will be imposed on a person who uses the microorganism obtained
from the depositary for non experimental purposes? 315
12.14.5 For the purposes of Rule 28(4), when are the technical preparations for publication of
the application completed? 315
12.14.6 Is an expert under Rule 28(5) permitted to pass the microorganism on to the party
requesting the deposited culture? 316
12.14.7 Does use of the expert solution system conflict with German Patent Law? 316
12.14.8 How is the expert solution option indicated in the Article 93 publication of a
European application? 317
12.14.9 What are the requirements if the applicant and the depositor are not the same person 317
13 Priority: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 319
13.1 Priority: EPO (Arts. 87 to 89 EPC) 319
13.2 Priority: US 323
13.3 Priority: JPO 334
14 Priority: The EPO s Case Law 337
14.1 T 81/87, »Preprorennin/COLLABORATIVE«, EP A 57 350, OJ EPO 1990,250 .. 337
14.2 T 269/87, »Prochymosin/CELLTECH«, EP A 68 691 338
14.3 T 301/87, »Alpha interferons/BIOGEN«, EP B 32134, OJ EPO 1990,335 339
14.4 T 886/91, »Hepatitis B virus/BIOGEN«, EP B113 828 339
14.5 T 296/93, »HBV antigen production/BIOGEN«, EP B1182 442, OJ EPO 1995,627 340
14.6 T 65/92, »HTLV/HARVARD COLLEGE*, EP A 151579 341
14.7 T207/94,»Fibroblastinterferon/BIOGEN«,EP B141313 342
14.8 T 441/93, »Cloning in Kluyveromyces/GIST BROCADES«, EP B1 96 430 343
14.9 T 413/94, »Human GM CSF/IMMUNEX CORP.«, EP B1183 350 344
14.10 T 380/94, »Insectcontrol/PGS«,EP Bl 193259 345
14.11 T 277/95 »Production of erythropoietin/GENETICS INSTITUTE*,
EP B1411678 346
14.12 T 236/96, »Interleukin 1/DAINIPPON«, EP B1188 920 347
14.13 T 919/93, »Heat treated factor VIII/CEDARS SINAI«, EP B1 94 611 348
14.14 T 51/95, »Mature leukocyte interferons/HOFFMANN LA ROCHE«,
EP B1211148 348
14.15 T 1112/96, »Erythropoietinproduction/GENETICS INSTITUTE*, EP B1205 564 348
XX
Contents
14.16 T 542/95, »TNF/YEDA«,EP B1186 833 349
14.17 T 1147/98, »Cartilage inducing factor/CELTRIX PHARMACEUTICALS INC.«,
EP B1169016 350
14.18 T 188/97, »NANBV/Chiron Corporations EP B1 318 216 350
14.19 T 479/97, »Expression system/NOVARTIS«, EP B1 353 188 351
14.20 T 351/98, »HIV I/CHIRON CORPORATION*, EP B1181150 352
14.21 T 342/98, »A. orizae/NOVOZYME, EP B1 238 023 353
14.22 T 93/98, »TNF inhibiting protein/BASF«, EP B1471 701 354
14.23 T 1099/99, »Filamentous fungi/GENENCOR*, EP B1215 594 355
14.24 T 216/96, »Process for amplifying, detecting and/or cloning nucleic acid sequences/
F.HOFFMANN LA ROCHE AG«,EP B1200 362 356
14.25 T 785/97, »Support bound oligonucleotides/OXFORD GENE TECHNOLOGY
LIMITED*, EP B1386 229 357
14.26 T 280/00, »Inhibin/GENENTECH«, EP B1222 491 357
14.27 T 120/00, »Mycobacteria/COGENT«, EP B1460 041 357
14.28 T 279/00, »Asymmetric reductionprocess/AVECIA LTD.«, EP B1 658 211 358
14.29 T 356/00, »Mammary gland FIX intron construct/PPL«, EP B1 396 699 359
14.30 T 552/00, »3D MPL/SMITHKLINE«, EP B1 689 454 360
14.31 T 1127/00, »Ribozymes/GENE SHEARS«, EP B1 321 201 360
14.32 T 8/01, »Chimeric chain receptors/CELL GENESYS«, EP B1 517 895 361
14.33 T 351/01, »Tissue factor protein/GENENTECH«, EP B1278 776 361
14.34 T 423/01, »Lengthpolymorphisms/MAX PLANCK GESELLSCHAFT«,
EP B1 438 512 362
14.35 T 486/01, »IGF 1/GENENTECH, INC.«, EP B1597 033 363
14.36 T 1014/01, »Recombinant immunoconjugates/BRISTOL MYERS SQUIBB CO.«,
EP B1 439 095 364
14.37 T 1080/01,»Thermostableenzyme/F.HOFFMANNLAROCHE«,EP B1258017 364
14.38 T 1074/00, »Hematopoietic growth factors/GENETICS INSTITUTE*,
EP B1 314 705 365
14.39 T 843/03, »Human papillomavirus/THE UNIVERSITY OF ROCHESTER*,
EP A 688 227 366
14.40 T 15/01, »Mystery swine disease/SDLO«, EP B1 587 780 366
14.41 T 20/04, »Flt3 ligands/SCHERING«, EP B1 699 236 368
15 Novelty: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 369
15.1 Novelty: EPO (Art. 54 EPC) 369
15.2 Novelty:US 382
15.3 Novelty:JPO 393
16 Novelty: The EPO s Case Law 401
16.1 Decisions on Novelty for Protein Inventions 401
16.1.1 T 877/90, »T cell growth factor/HOOPER«, EP B 49 611 401
16.1.2 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 402
16.1.3 T 187/93, »Vaccines/GENENTECH«, EP B1139 417 404
16.1.4 T 367/95, »Antihemophilic factor/PHARMACIA«, EP B1197 901 404
16.1.5 T 656/94,»Colony stimulating factor/KIRIN AMGEN«, EP B1237 545 405
16.1.6 T 493/94, »CSF/CHUGAI«, EP B1169 566 406
16.1.7 T 51/95, »Mature leukocyte interferons/HOFFMANN LA ROCHE«,
EP B1211148 407
16.1.8 T 767/95, »Interleukin l/IMMUNEX CORPORATION*, EP B1165 654 407
16.1.9 T 1147/98,»Cartilage inducing factor/CELTRIX PHARMACEUTICALS INC.«,
EP B1169 016 • 407
XXI
Contents
16110 T 378/95, »Factor VIIIC/CHIRON*, EP B1150 735 408
16.1.11 T 1208/97, »Analogs/AMGEN«, EP B1309 565 408
16.1.12 T 479/97, »Expression system/NOVARTIS«, EP B1 353 188 409
16.1.13 T 429/96, »Serine protease inhibitors/AMGEN*, EP B1205 555 409
16.1.14 T 450/98, »BPI fragments/NEW YORK UNIVERSITY*, EP B1 375 724 410
16.1.15 T 93/98, »TNF inhibiting protein/BASF«, EP B1 471 701 410
16.1.16 T 944/99,»Pesticidaltoxins/MYCOGENCORPORATIONSEP B1340948 .... 411
16.1.17 T 58/00, »Hepatic growth factor/MITSUBISHI«, EP B1412 557 411
16.1.18 T 1072/00, »Borreliaburgdorferi/MIKROGEN«, EP B1 506 868 411
16.1.19 T 787/00, »Erythropoietin/AMGEN«, EP B1 428 267 412
16.1.20 T 610/01, »Plant growth/LONG ASHTON RESEARCH STATION*,
EP A 703 983 412
16.1.21 T 836/01, »Interferon beta2/YEDA RESEARCH AND DEVELOPMENT CO.
LTD.«, EP A 835 661 413
16.1.22 T 1120/01, »Cell surface antigen/OSAKA BIOSCIENCE*; EP A 510 691 413
16.1.23 T 1080/01, Thermostable enzyme/F. HOFFMANN LA ROCHE«, EP B1258 017 414
16.1.24 T 458/02, »Hydrolized collagen/STOESS AG«, EP A 777 491 415
16.1.25 T 537/02, »Detergent composition/UNILEVER«, EP B1 563 103 415
16.1.26 T 734/00, »Novel Borrelia vaccine/SYMBICOM AB«, EP A 711 563 416
16.1.27 T 1127/02, »Soluble and insoluble form of an antigen/CONNAUGHT«,
EP B1588 578 416
16.1.28 T 1201/02, »Heparanase/INSIGHT STRATEGY*, EP A 998 569 416
16.1.29 T 93/03, »Lymphotoxin/GENENTECH«, EP A 768 889 417
16.1.30 T 157/03, »Reducing blood loss/ZYMOGENETICS«, EP B1 624 095 418
16.1.31 T 90/03, »Phytase/BASF«, EP A 779 037 418
16.2 Decisions on Novelty for DNA Sequence Inventions 419
16.2.1 T 53/87, »Mitochondrial DNA/HOECHST AG«, EP A 66 249 419
16.2.2 T 301/87, »Alpha interferons/BIOGEN«, EP B 32134, OJ EPO 1990,335 419
16.2.4 Opposition Division, »Relaxin« and T 272/95, »Relaxin/HOWARD FLOREY
INSTITUTE*, EP B1112149, OJ EPO 1995,388 420
16.2.5 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 421
16.2.6 T 128/92, »Interleukin 2/AJINOMOTO«, EP B10 091539 421
16.2.7 T 236/96, »Interleukin 1/DAINIPPON«, EP B1188 920 422
16.2.8 T 1112/96, »Erythropoietinproduction/GENETICS INSTITUTE*, EP B 1205 564 422
16.2.9 T 838/97, »Translationalinhibition/RESEARCH FOUNDATION*,
EP B1140308 .. 423
16.2.10 T 280/00, »Inhibin/GENENTECH«, EP B1222 491 424
16.2.11 Tll20/00,»Soybeandesaturase/DUPONT«,EP B1537178 424
16.2.12 T 423/01, »Lengthpolymorphisms/MAX PLANCK GESELLSCHAFT«,
EP B1438 512 426
16.2.13 T 340/00, »Thermostable enzyme/F. HOFFMANN LA ROCHE*, EP B1395 736 426
16.2.14 T 656/03, »Factor VIII/BIOVITRUM*, EP Bl 506 757 427
16.3 Decisions on Novelty of Inventions Relating to Systems for the Expression of DNA
Sequences 428
16.3.1 T 158/91, »Human growth hormone/GENENTECH*, EP A l27 305 428
16.3.2 T 782/91, »Expressing a gene/KYOWA«, EP Bl 88 166 430
16.3.3 T207/94,»Fibroblastinterferon/BIOGEN*,EP Bl41 313,OJEPO1999,273 .... 431
16.3.4 T901/94,»Methodofimprovingyields/CETUSONCOLOGY«,EP Bl 156 355 . 432
16.3.5 T916/94,»Refractileprotein/GENENTECH«,EP B1114 506 432
16.3.6 T 277/95, »Production of erythropoietin/GENETlCS INSTITUTE*,
EP Bl 411 678 433
16.3.7 T 746/94,»Polypeptideisolation/BERLEX*,EP Bl 183 776 434
16.3.8 T 745/96, » Animal cell culture/ALUSUISSE HOLDINGS A.G.«, EP Bl 229 809.. 434
XXII
Contents
16.3.9 T 354/97, »Proteinsecretion/GENENTECH«, EP Bl 88 632 435
16.3.10 T 1099/99, »Filamentous fungi/GENENCOR«, EP Bl 215 594 435
16.3.11 T 1092/98, transformed cells/ZYMOGENETICS«, EP Bl 171142.. 436
16.3.12 T 356/00, »Mammary gland FIX intron construct/PPL«, EP Bl 396 699 436
16.3.13 T 15/00, »Serum albumin/DELTABIOTECH«, EP Bl 386 222 437
16.3.14 T 100/01, »Variantproteins/GENENTECH, INC.«, EP Bl 564 531 437
16.3.15 T 522/99, »Human parvovirus B19 proteins/RIJKSUNIVERSITEIT LEIDEN«,
EP Bl 491 824 438
16.3.16 T 882/01, »Protein expression system/CELLTECH«, EP Bl 651 803 438
16.3.17 T 199/02, »Targeted destruction of neoplastic cells/THE GENERAL HOSPITAL
CORPORATIONS EP Bl 476 953 439
16.3.18 T 729/99, »Homologous recombination/INSTITUTPASTEUR«, EP Bl 419 621 .. 440
16.4 Decisions on Novelty for Plasmid Inventions 441
16.4.1 T 109/91, »Compositeplasmid/AJINOMOTO«, EP B 93 611 441
16.4.2 T 576/91, »Plasmid pTR2030/NORTH CAROLINA STATE«, EP A 208 468 443
16.4.3 T 339/93, »Recombinant vaccinia virus/HEALTHRESEARCH*, EP Bl 83 286 ... 444
16.5 Decisions on Novelty for Inventions on Antibody Technology 445
16.5.1 T 3/89, »Determination of antigens/AKZO«, EP A 45 103 .. 445
16.5.2 T 130/90, »Recombinant monoclonal antibody/UNIVERSITY OF TEXAS
SYSTEM«, EP B 68 763 446
16.5.3 T 431/96, »Monoclonal antibody/AGEN«, EP Bl 122 478 446
16.5.4 T 542/95,»TNF/YEDA«,EP Bl 186833 446
16.5.5 »Radiolabelled antibodies/RHOMED INC.«, EP Bl 234 612 447
16.5.6 T 669/97, »Chimeric antibodies/CELLTECH THERAPEUTICS LTD«,
EP Bl 194276 447
16.5.7 T 400/97, »Immunoglobulins/CELLTECH«, EP Bl 120 694 447
16.5.8 T 1212/97, »Immunoglobulin preparations/GENENTECH«, EP Bl 125 023 449
16.5.9 T 735/00, »Anti CRP antibodies/IATRONLABORATORIES, INC.«, EP Bl 431
171 451
16.5.10 T 1014/01, »Recombinant immunoconjugates/BRISTOL MYERS SQUIBB CO.«,
EP Bl 439 095 452
16.5.11 T 877/03, »Anti CD30 antibodies/ROCHE«, EP Bl 805 871 453
16.5.12 T 626/00, »Framework mutated antibodies/WELLCOME«, EP Bl 549 581 453
16.6 Decisions on Novelty for Plant Inventions 453
16.6.1 T 612/92, »Monocotyledonous plants/RIJKSUNIVERSITEIT LEIDEN«,
EP Bl 159418 453
16.6.2 T 951/93, »Chamomile drug/ROBUGEN«, EP 89 10 3429.0 454
16.6.3 T 387/94, »Chimeric genes/MONSANTO«, EP Bl 131 623 455
16.6.4 T 464/94, »Transformation of plant genetic material/NOVARTIS«, EP Bl 164 575 . 456
16.6.5 T 741/94, »Parasite resistance/DUKE«, EP A 215 907 457
16.6.6 T 1054/97, »Insect control/AVENTIS«, EP Bl 451 878 458
16.6.7 T 149/98, »Resistance development/Bayer«, EP Bl 408 403 458
16.6.8 T 579/01, »Cytoplasmic male sterile plants/ENZA ZADEN«, EP Bl 771 523 459
16.6.9 T 1006/02, »Selection of transformed cells/SYNGENTA«, EP Bl 601 092 459
16.6.10 T 1026/02, »Oilseed brassica/PIONEER HI BRED INTERNAT.«, INC.«,
EP A 891130 460
16.6.11 T 890/02, »Chimeric gene/BAYER«, EP A 828 837 460
16.7 Viruses and Their Epitopes 461
16.7.1 T 886/91, »Hepatitis B virus/BIOGEN«, EP Bl 13 828 461
16.7.2 T 815/90 »Hepatitis A virus/UNITED STATES OF AMERICA*, EP A 196 316 .. 462
16.7.3 T 977/93, »Canine coronavirus vaccine/AMERICAN HOME PRODUCTS CO.«,
EP B 1145 783, OJ EPO 2001,84 462
16.7.4 T 383/97, »Hepatitis C virus/ROCHE«, EP A 564 532 464
XXIII
Contents
16.7.5 T 351/98, »HIV I/CHIRON CORPORATION*, EP B1181150 465
16.7.8 Tl 137/97, »Marek s Disease Virus Vaccine/AMERICAN HOME PRODUCTS
CORPORATION*, EP B1496135 465
16.7.9 T 108/98, »HSV glycoproteins/DADE BEHRING«, EP B1 139 416 466
16.7.10 T 583/03, »Human packaging cell line/CHIRON«, EP A 854193 467
16.7.11 T 451/99, »AIDS related disease/BIO RAD LABS.«, EP B1220 273 467
16.7.12 T 10/01, »AIDS polypeptides/GENENTECH«, EP B1187 041 469
16.7.13 T 15/01, »Mystery swine disease/SDLO«, EP Bl 587 780 469
16.8 PCR and Other in vitro Nucleic Acid Amplification and Detection Methods 470
16.8.1 Opposition Division, »PCR/Hoffmann La Roche« (December 14,1995),
EP B1201184, and the Technical Board s later decision T 78/96, »Process for
amplifying nucleic acid sequences/F. HOFFMANN LA ROCHE AG« 470
16.8.2 T 216/96, »Process for amplifying, detecting and/or cloning nucleic acid sequences/
F. HOFFMANN LA ROCHE AG«,EP B1200 362 473
16.8.3 T 902/94, »DNA amplification/BAYLOR COLLEGE OF MEDICINE*,
EP A 364 255 474
16.9 Microorganisms and How to Modify Them 475
16.9.1 T 70/85, »Microbial transformation/SHELL«, EP A 54 987 475
16.9.2 T 78/95, »Penicilliumchrysogenum/ANTIBIOTICOS«,EP Bl 235 951 476
16.9.3 T 295/96, »Gene amplification/GIST BROCADES*, EP B1284126 476
16.9.4 T 430/96, »Aspergillus/GIST BROCADES N.V.«, EP B1184 438 477
16.9.5 T 36/00, »Proteinase deficient fungi/GENENCOR«, EP B1 429 490 478
16.9.6 T 1070/00, »Antibiotic clustered genes/DSM«, EP B1 357119 478
16.10 Other Decisions onNovelty 479
16.10.1 G 1/92, »Availability to the public*, OJ EPO1993,277 479
16.10.2 T 657/92, »Microorganisms/MYCOGEN«, EP A 200 344 480
16.10.3 T 645/90, »Fermentedmilkproducts/MICROLIFE*, EP B1 0 111 020 482
16.10.4 T 879/94, »Human G CSF/CHUGAI*, EP B1 217 404 482
16.10.5 T 131/95, »01igonucleoside/JOHNS HOPKINS*, EP A 266 099 483
16.10.6 T 919/93, »Heat treated factor VIII/CEDARS SINAI*, EP Bl 94 611 483
16.10.7 T 744/97, »Detectionofmicrobes/EDBERG,S.«, EP Bl 254 771 484
16.10.8 T 71/95, »Immunoassay/AMERSHAM INTERNATIONAL plc«, EP Bl 324 540. 485
16.10.9 T 138/95, »Intrapulmonary delivery/GENENTECH INC.*, EP Bl 257 956 485
16.10.10 T 985/95, »Treatment of infertility/NOVO NORDISK A/S«, EP Bl 300 021 485
16.10.11 T 466/96»Biocatalyst/KLEIN«, EP Bl 173 915 485
16.10.12 T 867/97, »Proteinhydrolysates/NOVARTIS«, EP Bl 421 309 486
16.10.13 T 800/99, »Cancer therapy/SIDNEY KIMMEL CANCER CENTER*,
EP A 758 382 487
16.10.14 T 989/98»Antigenicconjugates/OHIO«,EP B662839 487
16.10.15 T 247/97, »Augmentation materials from the placenta/INSTITUT CLAYTON DE
LARECHERCHE*, EP Bl 285 370 488
16.10.16 T 269/97, »Composition for treating insufficiency of the pancreas/SHARP]i«,
EP Bl 387 945 488
16.10.17 T 291/97, »Hormones/PROTHERICS MOLECULAR DESIGN LIMITED*
EP A293530 489
16.10.18 T 795/98, »Biologicalprocess/aktieselskabetfaxekalkbrud«, EP Bl 461166 489
16.10.19 T 295/99, »Glucose 6 Phosphate/IATRON«, EP Bl 469154 490
16.10.20 T 669/01, »Growthhormone/PHARMACIA AB«, EP A 707 491 491
16.10.21 T 343/00, »Creamyeast/DSMN.V.«, EP Bl 461 725 491
16.10.22 T 785/97, »Support bound oligonucleotides/OXFORD GENE TECHNOLOGY
LIMITED*, EP Bl 386 229 492
16.10.23 T310/99,»DownSyndrome/MACRI*,EP Bl409956 492
XXIV
Contents
16.10.24 T 919/99, »Neonatal hematopoietic stem cells/PHARMASTEM
THERAPEUTICS*, EP B1 343 217 492
16.10.25 T 505/00, »Anti free PSA antibody/LILJA«, EP B1 540 573 493
16.10.26 T 552/00, »3D MPL/SMITHKLINE«, EP B1689 454 493
16.10.27 T 676/00, »Cell culture medium/CHIRON«, EP B1 435 911 494
16.10.28 T 846/00, »Thrombus detection/ANTISOMA LIMITED«, EP B1429 626 494
16.10.29 T 635/00, »Hybridisation sandwich/BIO MERIEUX«, EP B1486 661 495
16.10.30 T 737/00, »Sweetener/SUDZUCKER«, EP B1 625 578 495
16.10.31 T 1076/00, »Vaccine against drugs/CHILKA Ltd.«, EP B1496 839 496
16.10.32 T 1127/00, »Ribozymes/GENE SHEARS*, EP B1 321201 497
16.10.33 T 166/01,»Invitromethod/KAROBIOAB«,EP B1 607268 498
16.10.34 T 881/01, »Alpha amylase reagent/MODROVICH I.E.«, EP B1 568 959 498
16.10.35 T 1028/01, »Immunoglobuline solutions/OCTAPHARMA«, EP B1 525 502 499
16.10.36 T 812/02, »Microanalysis of samples on disc/REMACLE«, EP A 1 044 375 500
16.10.37 T 870/02, »Transmembrane potentials/REGENTS CALIFORNIA*,
EP B1 834 074 500
16.10.38 T 1090/02, »Luciferase/PROMEGA«, EP B1 553 234 501
16.10.39 T 729/00, »Screening method/HOUSEY«, EP B1 403 506 502
16.10.40 T 1092/01, »Lutein/INDUSTRIAL ORGANICA«, EP B1 741 795 502
16.10.41 T 509/04, »Cerebralpalsy/ALLERGAN«, EP B1 605 501 503
17 Inventive Step: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 505
17.1 Inventive Step: EPO (Art. 56 EPC) 505
17.2 Inventive Step: US 517
17.3 Inventive Step: JPO 530
18 Inventive Step: The EPO s Case Law 541
18.1 Decisions on Inventive Step for Protein Inventions (Including Inventions Relating to
Methods for the Preparation of Proteins and their Use) 541
18.1.1 T 419/87, »Single cell protein material/PHILLIPS PETROLEUM COMPANY*,
EP B 17 853 541
18.1.2 T 249/88, »Milkproduction/MONSANTO«, EP A 85 036 542
18.1.3 T 877/90, »T cell growth factor/HOOPER*, EP B 49 611 543
18.1.4 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 543
18.1.5 T 379/94, »Treatmentof leukaemias/SCHERING*, EP B1 276120 544
18.1.6 T 758/94, »Subtilisin analogs/AMGEN«, EP B1 254 735 545
18.1.7 T 187/93, »Vaccines/GENENTECH« (March 5,1997), EP B1139 417 546
18.1.8 T 202/95, »Alpha h ANP/FUJISAWA«, EP Bl 206 769 546
18.1.9 T 656/94,»Colony stimulatingfactor/KIRIN AMGEN*, EP Bl 237545 547
18.1.10 T 493/94, »CSF/CHUGAI«, EP Bl 169 566 547
18.1.11 T 51/95, »Mature leukocyte interferons/HOFFMANN LA ROCHE«,
EP Bl 211148 548
18.1.12 T 223/96, »Protein C/ELI LILLY*, EP Bl 191 606 548
18.1.13 T 767/95, »Interleukin l/IMMUNEX CORPORATION*, EP Bl 165 654 549
18.1.14 T 743/97, »Thrombolyticproteins/GENETlCS INSTITUTE*, EP Bl 293 394 .... 550
18.1.15 T 1147/98, »Cartilage inducingfactor/CELTRIXPHARMACEUTICALS INC.*,
EP Bl 169 016 551
18.1.16 T 378/95, »Factor VIIIC/CHIRON«, EP Bl 150 735 551
18.1.17 T 1208/97, »Analogs/AMGEN«, EP Bl 309 565 551
18.1.18 T 429/96, »Serineproteaseinhibitors/AMGEN«, EP Bl 205 555 552
18.1.19 T 749/98, »Cellulase/NOVOZYMES A/S«, EP Bl 531372 552
XXV
Contents ——
18.1.20 T 450/98, »BPI fragments/NEW YORK UNIVERSITY*, EP B1 375 724 553
18 121 T 465/98, »Haemophilus pleuropneomoniae/CENTRAAL DIERGENEESKUN
DIGINSTITUUT«,EP B1354628 553
18 1 22 T 750/98,»Outer membrane protein/CYANAMID«, EP B1 449 958 554
18.1.23 T 338/00, »Multimeric receptors/SALK INSTITUTE*, EP B1 619 842 554
18 1 24 T 446/99, »Bordetella toxin/AMGEN«, EP B1306 318 556
18.1.25 T 944/99, »Pesticidal toxins/MYCOGEN CORPORATION*, EP B1 340 948 .... 557
18.1.26 T 58/00, »Hepatic growth factor/MITSUBISHI*, EP B1 412 557 557
18.1.27 T 1072/00, »Borrelia burgdorferi/MIKROGEN«, EP B1 506 868 557
18.1.28 T 787/00, »Erythropoietin/AMGEN«, EP B1428 267 558
18.1.29 T 189/01, »IFN P2/IL 6R/YEDA RESEARCH AND DEVELOPMENT CO.,
LTD.«,EP B1413 908 558
18.1.30 T 210/01, »IL 4 mutant proteins/BAYER«, EP B1 613 499 559
18.1.31 T 493/01, »Acellularvaccine/CELLTECH«, EP B1 573 435 559
18.1.32 T 486/01, »IGF 1/GENENTECH, INC.«, EP B1597 033 560
18.1.33 T 610/01, »Plantgrowth/LONG ASHTON RESEARCH STATION*,
EP A 703 983 560
18.1.34 T 1037/01, »Factor VIII/IMMUNO«, EP B1 567 448 560
18.1.35 T 1080/01,»Thermostableenzyme/EHOFFMANNLAROCHE«,EP B1258017 561
18.1.36 T 458/02, »Hydrolized collagen/STOESS AG«, EP A 777 491 561
18.1.37 T 537/02, »Detergent composition/UNILEVER*, EP B1 563 103 562
18.1.38 T 734/00, »NovelBorreliavaccine/SYMBICOM AB«, EP A 711563 562
18.1.39 T 889/02, »Membrane cofactor protein/WASHINGTON UNIVERSITY*,
EP A 483 247 562
18.1.40 T 986/02, »Anticytokine/YEDA«, EP A 512 528 563
18.1.41 T 1127/02, »Soluble and insoluble form of an antigen/CONNAUGHT*,
EP B1 588 578 564
18.1.42 T 93/03, »Lymphotoxin/GENENTECH«, EP A 768 889 564
18.1.43 T 157/03, »Reducing blood loss/ZYMO GENETICS*, EP B1 624 095 564
18.1.44 T 999/03, »CD protein/STATE UNIVERSITY OF NEW YORK«, EP A 737 085 . 565
18.1.45 T 292/01, »Plasmaproteins/CENTRE REGIONAL DE TRANSFUSION SAN¬
GUINE DELILLE«,EP B1 359593 565
18.2 Decisions on Inventive Step for DNA Sequence Inventions 567
18.2.1 T 301/87, »Alpha interferons/BIOGEN«, EP B 32 134, OJ EPO1990,335 567
18.2.2 T 500/91 »Alpha interferons II/BIOGEN«, EP B 32134 567
18.2.3 T 223/92, »Human y interferon/GENENTECH«, EP B 77 670 569
18.2.4 T 816/90, »CBH II/ALKO*, EP A 214 971 571
18.2.5 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 572
18.2.6 T 923/92, »t PA/GENENTECH«, EP B 193 619 574
18.2.7 T 128/92, »Interleukin 2/AJINOMOTO«, EP B1 0 091 539 576
18.2.8 T 495/92, »Gln interferonvariant/CANCER INSTITUTE*, EP B1112 976, and
T 510/92, »Novel human interferon y polypeptide/KYOWA HAKKO*,
EP B1121157 .. 577
18.2.9 T 386/94, »Chymosin/UNILEVER«, EP B1 77 109, OJ EPO 1996,658 578
18.2.10 T530/95,»XmaI/NEWENGLANDBIOLABS«,EP B1395 367 581
18.2.11 T 475/93, »IGF II/CHIRON«, EP B1189 481 582
18.2.12 T 656/94, »Colony stimulating factor/KIRIN AMGEN«, EP B1237 545 583
18.2.13 T 70/95, »Enhancer/HOECHST«, EP A1173 177 584
18.2.14 T 236/96, »Interleukin 1/DAINIPPON«, EP B1188 920 585
18.2.15 T 1092/96, »Interferon beta2A/YEDA RESEARCH*, EP B1220 574 585
18.2.16 T 223/96, »Protein C/ELI LILLY*, EP B1191606 586
18.2.17 T 1112/96, »Erythropoietinproduction/GENETICS INSTITUTE*,EP B 1205 564 587
XXVI
Contents
18.2.18 T 915/94, »Carbonyl hydrolases/GENENCOR INTERNATIONAL INC.«,
EP B1 130 756 587
18.2.19 T 637/97, »Bindingprotein/GENENTECH«, EP B1406 272 588
18.2.20 T 838/97, »Translational inhibition/RESEARCH FOUNDATION*,
EP B1140 308 589
18.2.21 T 479/97, »Expression system/NOVARTIS«, EP B1353 188 590
18.2.22 T 111/00, »Monokine/FARBER«, EP A 679186 590
18.2.23 T 343/98, »Fibroblast growth factor/THE SALK INSTITUTE FOR
BIOLOGICAL STUDIES*, EP B1228 449 591
18.2.24 T 272/95, »Relaxin/HOWARD FLOREY INSTITUTE*, EP B 1,112149 592
18.2.25 T 29/99, »Serine protease inhibitors/AMGEN«, EP Bl205 475 592
18.2.26 T 3/00, »Protease/SHIONOGI«, EP B1482 879 594
18.2.27 T 280/00, »Inhibin/GENENTECH«, EP B1222 491 594
18.2.28 T 8/01, »Chimeric chain receptors/CELL GENESYS«, EP B1 517 895 595
18.2.29 T 150/03, »Channelproteins/CHIBA UNIVERSITY*, EP A1 768 379 596
18.2.30 T 182/03, »Phosphodiesterase/SMITHKLINE BEECHAM«, EP A1 752 853 596
18.2.31 Tl 133/00, »Tumor suppression/UNIVERSITY OF CALIFORNIA*,
EP B1 475 623 597
18.2.32 T 351/01, »Tissue factor protein/GENENTECH«, EP B1278 776 597
18.2.33 T 423/01, »Lengthpolymorphisms/MAX PLANCK GESELLSCHAFT«,
EP B1438 512 597
18.2.34 T 1120/01, »Cell surface antigen/OSAKABIOSCIENCE«; EP A 510 691 598
18.2.35 T 875/02, »Microbial phytase/BASF«, EP B 1 420 358 598
18.2.36 T 340/00, »Thermostable enzyme/F. HOFFMANN LA ROCHE*, EP B1395 736 599
18.2.37 T 1074/00, »Hematopoietic growth factors/GENETICS INSTITUTE*,
EP B1 314 705 600
18.2.38 T 1093/02,»Nucleicacidsprobes/GEN PROBEINC.*,EP A272009 600
18.2.39 T 1201/02, »Heparanase/INSIGHT STRATEGY*, EP A 998 569 601
18.2.40 T 769/03, »Ileal bile acid transporter/WAKE FORREST UNIVERSITY*,
EP A 737 075 601
18.2.41 T 656/03, »Factor VIII/BIOVITRUM*, EP Bl 506 757 602
18.3 Decisions on Inventive Step of Inventions Relating to Systems for the Expression of
DNASequences 602
18.3.1 T 60/89, »Fusionproteins/HARVARD«, EP B 6 694 603
18.3.2 T 717/89, »Hepatitis B virus E antigens/BIOGEN*, EP A 75 395 603
18.3.3 T 455/91,»Expressionofpolypeptidesinyeast/GENENTECH«,EP Bl 60057 ... 604
18.3.4 T 782/91,»Expressingagene/KYOWA«,EP Bl 88 166 607
18.3.5 T 880/92 »Factor IX/TRANSGENE«, EP Bl 162 782 607
18.3.6 T 844/93, »Hepatitis B surface antigen invertebrate cell culture/GENENTECH«,
EP Bl 73 656 608
18.3.7 T 845/93, »Hepatitis B antigen in yeast/GENENTECH«, EP Bl 73 657 609
18.3.8 T 207/94,«Fibroblast interferon/BIOGEN*, EP Bl 41 313, OJ EPO 1999,273 610
18.3.9 T 413/94, »Human GM CSF/IMMUNEX CORP.*, EP Bl 183 350 612
18.3.10 T 901/94, »Method of improving yields/CETUS ONCOLOGY*, EP B 156 355 .. 613
18.3.11 T916/94,»Refractileprotein/GENENTECH«,EP B1114 506 613
18.3.12 T 67/95, »Parvovirus capsids/THE UNITED STATES OF AMERICA*,
EP A1441897 614
18.3.13 T 277/95, »Production of erythropoietin/GENETICS INSTITUTE*,
EP Bl 411 678 ... 615
18.3.14 T 746/94, »Polypeptide isolation/BERLEX«, EP Bl 183 776 615
18.3.15 T 745/96, »Animal cell culture/ALUSUISSE HOLDINGS A.G.«, EP Bl 229 809.. 615
18.3.16 T 791/96, »Pseudorabies/UPJOHN«, EP Bl 223 382; 617
18.3.17 T 680/98, improved vectors II/BIOGEN*, EP Bl 41 767 618
XXVII
Contents _^____
18.3.18 T 342/98, »A. orizae/NOVOZYME, EP B1238 023 618
18 3 19 T 224/99, »PDGF/ZYMOGENETICS«, EP B1177 957; 619
18.3.20 T 294/99, »Cysteine free peptides/TAKEDA LTD.«, EP B1 499 990 620
18.3.21 T 1099/99, »Filamentous fungi/GENENCOR«, EP B1215 594 621
18.3.22 T 747/01, »Filamentous fungi/DSM«, EP A1 768 383 621
18.3.23 T 1092/98, .Transformed cells/ZYMOGENETICS«, EP B1171142 622
18.3.24 T 620/99, »Homologous recombination/CELL GENESIS INC.«, EP B1 452 484 .. 622
18.3.25 T 356/00, »Mammary gland FIX intron construct/PPL«, EP B1 396 699 623
18.3.26 T 15/00, »Serum albumin/DELTA BIOTECH«, EP B1 386 222 624
18.3.27 T 100/01,»Variant proteins/GENENTECH, INC.«, EP B1 564 531 625
18.3.28 T 522/99, »Human parvovirus B19 proteins/RIJKSUNIVERSITElT LEIDEN«,
EP B1491 824 625
18.3.29 T 473/01, »Neorotransmitter uptake/BAYLOR COLLEGE*, EP B1 502 845 626
18.3.30 T 627/01, »Secretion of proteins/GENENTECH, INC«, EP B1 88 632 626
18.3.31 T 1059/01, »Human DNase/GENENTECH«, EP B1449 968 626
18.3.32 T 1102/00, »Mammalian membrane receptors/CNRS«, EP B1 344 024 627
18.3.33 T 199/02, »Targeted destruction of neoplastic cells/THE GENERAL HOSPITAL
CORPORATION*, EP B1476 953 627
18.3.34 T 893/02, »GP75/SLOAN KETTERING«, EP B1522 078 627
18.3.35 T 960/02, »Transfection/TRANSKARYOTIC THERAPIES*, EP B1649 464 628
18.3.36 T 729/99, »Homologous recombination/INSTITUT PASTEUR*, EP B1 419 621 .. 629
18.4 Decisions on Inventive Step for Plasmid Inventions 630
18.4.1 T 162/86, »Plasmid pSG2/HOECHST AG«, EP A 66 701, OJ EPO 1988,452 630
18.4.2 T 264/87, »Yeast transformant/ANVAR«, EP B 11 562 630
18.4.3 T 347/87, »Method of constructing a replicable cloning vehicle/GENENTECH*,
EP A 22 242 630
18.4.4 T 609/90, »Protecting bacteria/ELI LILLY*, EP A 105 608 630
18.4.5 T 339/93, »Recombinant vaccinia virus/HEALTH RESEARCH*, EP B1 83 286 ... 631
18.5 Decisions on Inventive Step for Inventions on Antibody Technology 633
18.5.1 T 499/88, »Immunoglobulins/UNILEVER«, EP A 59 598 633
18.5.2 T 36/90, »Tumor cells/BOGOCH«, EP A 676 642 634
18.5.3 T 683/90, »Tumor localization/GOLDENBERG*, EP B 35 265 634
18.5.4 T 906/91, »Monoclonal antibody to theophylline/DuPont*, EP B1 98 179 636
18.5.5 T 915/93, »Monoclonal antibody therapy/ORTHO*, EP A 222 617 640
18.5.6 T 355/92, »anti FSH antibody/BOEHRINGERMANNHEIM*, EP A 193 880 ... 641
18.5.7 T 478/92, »anti LH antibody/BOEHRINGER MANNHEIM*, EP A 193 881 .... 642
! 18.5.8 T 63/94, »Determinationofantigens/AKZONOBEL«,EP Bl 45103 642
18.5.9 T 958/93, »Quantitation of immunoglobulins/WAKO«, EP B1161 638 642
18.5.10 T 510/94, »Monoclonal antibody OKT5/ORTHO* (April 21,1998), EP B125 722 . 643
18.5.11 T 512/94, »Monoclonal antibody/ORTHO«, EP B1 30 815 644
18.5.12 T 513/94, »Monoclonal antibody (OKT3)/ORTHO«, EP B118 795 644
18.5.13 T 431/96, »Monoclonal antibody/AGEN«, EP B1122 478 644
18.5.14 T 457/95, »Immunoassay/ABBOTT LABORATORIES*, EP B1160 900 645
18.5.15 T 542/95,»TNF/YEDA«,EP B1186833 645
18.5.16 T 606/96, »Radiolabelled antibodies/RHOMED INC.*, EP B1 234 612 646
18.5.17 T 669/97, »Chimeric antibodies/CELLTECH THERAPEUTICS LTD*,
EP B1194276 646
18.5.18 T 1212/97,»Immunoglobulinpreparations/GENENTECH«,EP B1125023 ...... 646
18.5.19 T 753/00, »Production of proteins/B.R. CENTRE LIMITED*, EP B1 542 810 .... 647
18.5.20 T 886/00, »Immunoglobulin variable domain sequences/MEDICAL RESEARCH
COUNCIL*, EP B1 368 684 648
18.5.21 T 735/00, »Anti CRP antibodies/IATRON LABORATORIES, INC.*,
EP B1431171 649
XXVIII
Contents
18.5.22 T 1014/01, »Recombinantimmunoconjugates/BRISTOL MYERS SQUIBB CO.«,
EP B1 439 095 650
18.5.23 T 645/02, »Antibodies/EBERHARD KARLS UNIVERSITAT«, EP A 787 743 ... 651
18.5.24 T 278/03,»Antibody production/WELLCOME«, EP Bl 481 790 651
18.5.25 T 877/03, »Anti CD30 antibodies/ROCHE«, EP Bl 805 871 653
18.5.26 T 626/00, »Framework mutated antibodies/WELLCOME*, EP B1 549 581 654
18.6 Decisions on Inventive Step for Plant Inventions 655
18.6.1 T 694/92, »Modifying plant cells/MYCOGEN«, EP B1122 791 655
18.6.2 T 13/93, »Plant growth regulator/UNION OIL«, EP B1241 568 655
18.6.3 T 387/94, »Chimeric genes/MONSANTO«, EP B1 131 623 656
18.6.4 T 380/94, »Insect control/PGS«, EP B1193 259 658
18.6.5 T 425/96, »Tomato plants/MONSANTO«, EP Bl269 601 659
18.6.6 T 1051/96, »Genetic linkages/PIONEER«, EP A 402 401 659
18.6.7 T 303/95, »Chimeric gene/RH6NE POULENC«, EP A 337 899 660
18.6.8 T 338/97, »Molecular farming/CALGENE INC.«, EP B1233 915 661
18.6.9 T 1054/97, »Insects control/AVENTIS«, EP B1451 878 663
18.6.10 T 215/96, »Plant breeding/S G SEEDS B.V.«, EP B1361124 664
18.6.11 T 333/97, »Somatic changes/MONSANTO«, EP 0 223 399 665
18.6.12 T 1148/00, »Seed material/OYPANIMOLABORATORIO«, EP A 6778 120 667
18.6.13 T 1115/97, »Herbicide resistance in plants/MGIPHARMA,INC.«,EP Bl 154204 667
18.6.14 T 149/98, »Resistance development/Bayer«, EP B1 408 403 668
18.6.15 T 984/00, »Ti plasmid vectors/MAX PLANCK GESELLSCHAFT«,
EP A 290 799 669
18.6.16 T 475/01, »Phosphinotricine resistance gene/BAYER«,EP Bl 275 957 669
18.6.17 T 1198/01,»Vaccinesexpressedinplants/PRODIGENE,INC.«,EP A728014.... 669
18.6.18 T 579/01, »Cytoplasmic male sterile plants/ENZA ZADEN«, EP B1 771 523 670
18.6.19 T 1006/02, »Selection of transformed cells/SYNGENTA«, EP B1 601 092 670
18.6.20 T 890/02, »Chimeric gene/BAYER«, EP A 828 837 671
18.7 Viruses and Their Epitopes 672
18.7.1 T 261/89, »Human hepatitis Avirus/MERCK«, EP B 25 745 672
18.7.2 T 886/91, »HepatitisBvirus/BIOGEN«, EP Bl 13 828 672
18.7.3 T 296/93, »HBVantigen production/BIOGEN«, EP B1182 442 675
18.7.4 T 279/96, »Retrovirases/WHITEHEAD INSTITUTE*, EP A1432 216 676
18.7.5 T 145/95, »Newcastle disease virus/BTG«, EP B1227 414 677
18.7.6 T 977/93, »Canine coronavirus vaccine/AMERICAN HOME PRODUCTS CO.«,
EP B 1145 783 680
18.7.7 T 372/97, »Newcastle disease virus vaccine/YISSUM RESEARCH*, EP B 1292 293 680
18.7.8 T 448/96, »Virus free antihemophilic factor/CRTSL«, EP B1 343 275 681
18.7.9 T 188/97, »NANBV/Chiron Corporation*, EP B1 318 216 682
18.7.10 T 32/97, »Deleted tk PRV vaccines/NOVAGENE«, EP B1149 040 682
18.7.11 T 91/98, »Antiviral nucleosides/WELLCOME«, EP Bl 306 597 683
18.7.12 T 351/98, »HIV I/CHIRON CORPORATION*, EP Bl 181150 685
18.7.13 T 228/01, »Carcinoembryonic antigen/US GOVERNMENT*, EP A 584 266 686
18.7.14 T 239/95, »Herpes simplex viral proteins/AMERICAN CYANAMID CO.«,
EP Bl 101 655 687
18.7.15 T 108/98, »HSV glycoproteins/DADE BEHRING«, EP Bl 139 416 687
18.7.16 T 747/98, »HTLV III peptides/ORTHO«, EP Bl 261224 688
18.7.17 T 1097/99, »HIVpeptides/ADALTIS INC.*, EP Bl 326 490 688
18.7.18 T 1147/01,»PRRSvaccine/AKZONOBELN.V.«,EP B1610250 689
18.7.19 T 127/02, »Herpesvirus mutants stromal keratitis/HARVARD*, EP A 739 414 .... 690
18.7.20 T 454/03, »Viral vector/TRANSGENE*, EP Bl 742 834 690
18.7.21 T 451/99, »AIDS related disease/BIO RAD LABS.*, EP Bl 220 273 691
18.7.22 T 968/00, »Retroviral vectors/CELL GENESYS*, EP B 1 556 345 692
XXIX
Contents
18.7.23 T 15/01, »Mystery swine disease/SDLO«, EP Bl 587 780 692
18 8 PCR and Other in vitro Nucleic Acid Amplification and Detection Methods 693
18.8.1 T 289/96, »Detecting sequences/ZENECA«, EP B1 332 435 693
18 8.2 T 965/98, »DNA amplification/HOFFMANN LA ROCHE«, EP A 509 612 693
18.8.3 T 1118/98,»Nucleicacids/DUPONTDENEMOURS«,EP B1520039 694
18.8.4 T 78/96, »Process for amplifying nucleic acid sequences/E HOFFMANN LA
ROCHEAG«,EP B1201184 694
18.8.5 T 216/96, »Process for amplifying, detecting and/or cloning nucleic acid sequences/
F.HOFFMANN LA ROCHE AG«,EP B1200 362 695
18.8.6 T 749/00»Polynucleotide probes/ENZO BIOCHEM, INC.« (March 19,2003),
EP A1 525 821 6%
18.8.7 T 302/02, » Automated amplification/APPLERA«, EP B1236 069 697
18.9 Microorganisms and How to Modify Them 698
18.9.1 T 391/91, »Ice nucleating/UNIVERSITY OF CALIFORNIA*, EP A 112 342 698
18.9.2 T 441/93, »Cloning in Kluyveromyces/GIST BROCADES*, EP B1 96 430 698
18.9.3 T 78/95, »Penicillium chrysogenum/ANTIBIOTICOS*, EP Bl235 951 699
18.9.4 T 430/96, »Aspergillus/GIST BROCADES N.V.«, EP B1184 438 699
18.9.5 T 737/96, »Astaxanthin/DSM«,EP Bl 367765 700
18.9.6 T 630/92, »Salmonellavaccines/LELAND STANFORD JUNIOR UNIVER
SITY«,EP A 184086 701
18.9.7 T 36/00, »Proteinase deficient fungi/GENENCOR«, EP B1 429 490 702
18.10 Other Decisions onlnventive Step 703
18.10.1 T 148/88, »Watersoluble Peptides/PFRIMMER«, EP B 87 751 703
18.10.2 T 181/88, » Assaying reagent/UNITIKA«, EP A 89210 704
18.10.3 T 645/90, »Fermented milk products/MICROLIFE«, EP B1 0 111 020 705
18.10.4 T 137/92, immobilized lipase/NOVO«, EP B1140 542 705
18.10.5 T 698/93, »Amine removal/CPC«, EP B1132 674 705
18.10.6 T 850/92, »Glutamine di and tripeptides/PHARMACIA«, EP B1220 379 706
18.10.7 T 847/94, »Sterilization/ELOPAK SYSTEMS AG«, EP 89 30 4519.5 706
18.10.8 T 856/94, »Cell grafting/UNIVERSITY OF CALIFORNIA*, EP A 449 948 707
18.10.9 T 599/94, »Cultivating milk/ARLA«, EP B1 154 614 708
18.10.10 T 455/95, »Enzyme composition/CPI«, EP B1219 269 709
18.10.11 T 138/95, »Intrapulmonary delivery/GENENTECH INC.«, EP Bl 257 956 710
18.10.12 T 985/95,»Treatmentof infertility/NOVONORDISK A/S«,EP Bl 300021 711
18.10.13 T 466/96, »Biocatalyst/KLEIN«, EP Bl 173 915 711
18.10.14 T 867/97, »Protein hydrolysates/NOVARTIS«, EP Bl 421 309 711
18.10.15 T 966/98, »DNA detection/HOFFMANN LA ROCHE«, EP A 502 589 712
18.10.16 T 422/96, »Method for detecting an analyte/ENZO BIOCHEM«, EP Bl 212 670 .. 712
18.10.17 T 800/99, »Cancer therapy/SIDNEY KIMMEL CANCER CENTER«,
EP A 758 382 713
18.10.18 T 1044/99, »Ionophore antibiotics, EP A 615 544 !.!.!!! !!!!!!!!!! !!!!! 714
18.10.19 T 666/95, »Agent for the therapy of hemophilia A/AVENTIS BEHRING GMBH«,
EP Bl 255 651 715
18.10.20 T 911/95, »Medicinal composition^ RESEARCH, EP Bl 270 545 ............. 715
18.10.21 T 339/98, »Vitamin K dependent proteins/ELI LILLY«, EP Bl 363 126 .715
18.10.22 T 1045/98, »Eosinophilia/SCHERING«, EP Bl 367 596 716
18.10.23 T 704/01»Vaccineagainstcholesterol/ENTREMED«,EP A562020 .............. 717
18.10.24 T 455/96, »Blood substitute/BIOPURE CORPORATION*, EP Bl 277 289 718
18.10.25 T 247/97, »Augmentation materials from the placenta/INSTITUT CLAYTON DE
LA RECHERCHE*, EP Bl 285 370 718
18.10.26 T 251/97, »Factor XIII/HOECHST JAPAN LIMITED*, EP Bl 278 416 . 718
18.10.27 T 782/97, detecting agent/YALE UNIVERSITY*, EP Bl 149 654 719
XXX
Contents
18.10.28 T 795/98, »Biological process/AKTIESELSKABET FAXE KALKBRUD«,
EP B1 461166 720
18.10.29 T 919/93, »Heat treated factor VIII/CEDARS SINAI«, EP Bl 94 611 720
18.10.30 T 295/99, »Glucose 6 Phosphate/IATRON«, EP B1 469 154 721
18.10.31 T 343/00, »Cream yeast/DSM N.V.«, EP B1 461 725 721
18.10.32 T 785/97, »Support bound oligonucleotides/OXFORD GENE TECHNOLOGY
LIMITED*, EP B1 386 229 722
18.10.33 T 187/99, »Assay method/ORTHO«, EP B1149 565 722
18.10.34 T 310/99, »DownSyndrome/MACRI«, EP Bl 409 956 723
18.10.35 T 1038/00, »Apoptotic cells/NEXINS RESEARCH*, EP B1 755 516 723
18.10.36 T 505/00, »Anti free PSA antibody/LILJA«, EP B1 540 573 ......, 724
18.10.37 T 552/00, »3D MPL/SMITHKLINE«, EP B1 689 454 724
18.10.38 T 676/00, »Cell culture medium/CHIRON«, EP B1435 911 725
18.10.39 T 731/00,»Cleansing proteins/OCTAPHARMA«, EP B1 484 464 725
18.10.40 T 748/00, »Oligomerlibraries/AFFYMAX«, EP B1 604 552 726
18.10.41 T 635/00, »Hybridisation sandwich/BIO MERIEUX«, EP B1486 661 726
18.10.42 T 737/00, »Sweetener/SUDZUCKER«, EP Bl 625 578 727
18.10.43 T 1076/00, »Vaccine againstdrugs/CHILKA Ltd.«, EP Bl 496 839 727
18.10.44 T 1127/00, »Ribozymes/GENE SHEARS*, EP Bl 321201 727
18.10.45 T 182/00»IgE response/SCHERING«, EP Bl 327 283 729
18.10.46 T 728/99, »Factor VIII/IMMUNO AG«, EP Bl 496 723 729
18.10.47 T1101/00,»Bloodcoagulationdisorders/DAHLBACK«,EP Bl 608235 730
18.10.48 T 166/01, »In vitro method/KARO BIO AB«, EP Bl 607 268 730
18.10.49 T 285/01, »Bone resorption/WASHINGTON RESEARCH FOUNDATION*,
EP Bl 394 296 730
18.10.50 T 881/01, »Alpha amylase reagent/MODROVICH I.E.«, EP Bl 568 959 731
18.10.51 T 1024/01, isolation of nucleic acid/AKZO«, EP Bl 389 063 731
18.10.52 T 1028/01, »Immunoglobuline solutions/OCTAPHARMA«, EP Bl 525 502 732
18.10.53 T 1091/01, »Human c peptide/TOSOH«, EP Bl 484 961 732
18.10.54 T 812/02, »Microanalysis of samples on disc/REMACLE«, EP A1 044 375 733
18.10.55 T 699/02, »Fibrinogen solution/AVENTIS BEHRING GmbH«, EP A 554 570 .... 733
18.10.56 T 870/02, »Transmembranepotentials/REGENTS CALIFORNIA*,
EP Bl 834 074 734
18.10.57 T 1090/02, »Luciferase/PROMEGA«, EP Bl 553 234 734
18.10.58 T 543/04, »Appetite suppressant/CSIR«, EP A 973 534 734
18.10.59 T 505/03, Conjugated linoleic acid/LODERS CROKLAAN*, EP Bl 866 874 .... 735
18.10.60 T 729/00, »Screening method/HOUSEY*, EP Bl 403 506 735
18.10.61 T 250/02, »Pharmaceutical compositions/NITSAS*, EP Bl 835 120 736
18.10.62 T 940/02, »Use of a peptide/NOVO NORDISK A/S«, EP Bl 631 505 737
18.10.63 T 509/04, »Cerebral palsy/ALLERGAN«, EP Bl 605 501 737
19 Decisions of the EPO Dealing with Procedural Issues 739
19.1 Substantive Examination: General 739
19.1.1 T 283/88, »Plasminogenactivator/ABBOT«, EP A 37 687: Denial of Interview .... 739
19.1.2 T 800/90, »Hemophilia/QUEEN S UNIVERSITY*, EP A 129 998: Rejection of
Application Without Warning 740
19.1.3 T 188/92, »Grounds for appeal/BEECHAM*, EP A 207 589: Inadmissible Appeal . 741
19.1.4 T 299/86, »Monoclonal anti a IFN antibody/SECHER«, EP A 50129: Request for
Oral Proceedings 742
19.1.5 T 891/92, »Immunogenic peptides/MERCK*, EP A 218 531: Rejection of
Application on the Basis of New Arguments 742
XXXI
Contents
19.1.6 T 690/91, »Chymosin/CELLTECH«, EP A 68 691: Deviation From Ratio
Decidendi 743
19.1.7 T 1211/97, »Monoclonal antibodies/VELOS GROUP«, EP A1151128:
Reimbursement of AppealFee 744
19.1.8 T 1051/96, »Genetic linkages/PIONEER«, EP A 402 401: Scope of Claims in
Appeal 744
19.1.9 T 755/96, »Camptothecin derivatives/RESEARCH TRIANGLE INSTITUTE*,
EP A 418 099: Filing of New Claim Requests in Prosecution 745
19.1.10 T 1006/98, »DNA sequencing/HARVARD COLLEGE*, EP A 516 245:
Admissibility of Claims in Divisionals 745
19.1.11 T 280/99, »Tryptophan decarboxylase/CANADA«, EP A 425 597: New Ground for
Rejection of Application 746
19.1.12 T 610/01, »Plant growth/LONG ASHTON RESEARCH STATION«,
EP A703 983: Appeal on Behalf of the Wrong Party 746
19.1.13 T 715/01, »Glycosides/COGNIS«, EP A 646122: Grounds of Appeal Filed by the
Not Yet Registered Assignee of the Application 746
19.1.14 T 492/03, »Glycerine dehydrogenase/MAX PLANCK«, EP A 716 699: Refusal of
Application Based on a Surprising Ground Reimbursal of Appeal Fee 747
19.1.15 T 897/03, »Dermatophagoides allergens/IMMULOGIC PHARMACEUTICAL*,
EP A 623 168, and T 276/04, »Fibroblast growth factor/HUMAN GENOME
SCIENCES*, EP A 833 904: Improper Reasons for Refusal 747
19.1.16 T 1154/04, »Carrier material/INVITEK*, EP A 1278 834 748
19.2 Opposition Proceedings: Introduction of New Grounds 748
19.2.1 T 51/95, »Mature leukocyte interferons/HOFFMANN LA ROCHE«,
EP B1211148: New Ground of Opposition 748
19.2.2 T 736/95, »Fresh ground of opposition/AMGEN«, EP B1108 128 749
19.2.3 T 422/96, »Method for detecting an analyte/ENZO BIOCHEM«, EP B1212 670:
New Ground of Opposition 749
19.2.4 T 29/99, »Serine protease inhibitors/AMGEN«,EP B1205 475: Admissibility of
New Arguments at Oral Proceedings 750
19.2.5 T 620/99, »Homologous recombination/CELL GENESIS INC.«, EP B1452 484:
Ground for Opposition Raised by Others in Opposition Proceedings 750
19.2.6 T 279/00, »Asymmetric reduction process/AVECIA LTD.*, EP Bl 658211:
Imperfect Grounds for Appeal; New Ground for Opposition 750
19.2.7 T 1100/01, »Truncated transmembrane PACE/GENETICS*, EP B1 574 402:
Introduction of a New Ground For Opposition by the Opposition Division 751
19.3 Opposition Proceedings: The Filing of New Claim Requests 752
19.3.1 T 13/93, »Plant growth regulator/UNION OIL«, EP B1241 568: Admissibility of
Auxiliary Requests 752
19.3.2 T 339/93, »Recombinant vaccinia virus/HEALTH RESEARCH*, EP B1 83 286:
Admissibility of Auxiliary Requests 752
19.3.3 T 794/94, »Polypeptide expression/GENENTECH III*, EP Bl 1 929:
Admissibility of Auxiliary Requests 752
19.3.4 T 493/94, »CSF/CHUGAI«, EP Bl 169 566: Admissibility of Auxiliary Requests . 753
19.3.5 T 218/97, »t PA deletionmutants/GENENTECH*, EP Bl 365 597: Remittal to
First Instance , 754 .
19.3.6 T 160/99, »Chlamydia/WASHINGTON«, EP Bl 264 434: Admissibility of New
Claim Request in Oral Proceedings 754
19.3.7 T 1097/99, »HIV peptides/ADALTIS INC.«, EP Bl 326 490: Admissibility of New
Request in Oral Proceedings 755
19.3.8 T 189/01,»IFN p2/IL 6R/YEDARESEARCHANDDEyELOPMENTCO.,
LTD.*, EP Bl 413 908: Inadmissibility of Claims Submitted in Appeal Proceedings
That Are Broader Than Those Submitted With The Appeal 755
XXXII
Contents
19.3.9 T 882/01, »Protein expression system/CELLTECH«, EP B1 651 803: Strategy to
Delay Proceedings by Filing Claim Requests Late is an Abuse 756
19.3.10 T 796/02, »Hepatitis B antigen/GENENTECH«, EP B173 657: Abuse of Procedure
by Claim Request 756
19.3.11 T 454/03, »Viralvector/TRANSGENE«,EP Bl 742 834 756
19.3.12 T 15/01, »Mystery swine disease/SDLO«, EP B1 587 780 757
19.4 Opposition Proceedings: The Filing of New Documents/Experimental and Other
Evidence and the Submission of New Arguments 757
19.4.1 T 97/90, »Lubricants/TAKEMOTO YUSHI«, EP B1145 150: Late Submission in
Opposition Proceedings 757
19.4.2 T 342/98, »A. orizae/NOVOZYME, EP B1238 023: Late Submission of
Experimental Reports 758
19.4.3 T 785/97, »Support bound oligonucleotides/OXFORD GENE TECHNOLOGY
LIMITED*, EP B1 386 229: Late Filed Document Admitted 759
19.4.4 T 120/00, »Mycobacteria/COGENT«, EP B1460 041: Late Submission of
Experimental Report 759
19.4.5 T 397/02, »Endogenous gene expression/APPLIED RESEARCH SYS«,
EP B 505 500: Late Filed Documents and Experimental Evidence 759
19.4.6 T 340/00, »Thermostable enzyme/HOFFMANN La ROCHE«, EP B1395 736:
Prior Use/Prior Sales, Late Filed Evidence 760
19.5 Opposition Proceedings: Adaption of the Description 761
19.5.1 T 636/97, »Erythropoietin II/KIRIN AMGEN«, EP B1148 605: Adaption of
Description 761
19.6 Opposition Proceedings: Third Party Intervention 762
19.6.1 T 886/91, »HepatitisBvirus/BIOGEN«,EP Bl 13 828: Third Party Intervention .. 762
19.6.2 T 296/93, »HBV antigen production/BIOGEN«, EP B1182 442: Third Party
Intervention 762
19.6.3 T 780/95, »Antigenic preparations/EVANS MEDICAL«, EP B1162 639: Third
Party Intervention 763
19.6.4 T 188/97, NANBV/Chiron Corporations EP B1318216: ThirdParty Intervention 763
19.6.5 T 694/01, »Testdevice/UNILEVER«,EP Bl 291194: Third Party Intervention ... 764
19.6.6 T 103 8/00,»Apoptotic cells/NEXINS RESEARCH*, EP B 1 755 516: Intervention
After Abandoning Proceedings, Admissibility of Auxiliary Requests 765
19.7 Opposition Proceedings: Strawman 766
19.7.1 The Filing of an Opposition by a Strawman 766
19.8 Opposition Proceedings: Substantial Procedural Violation and Failures in the
Opposition Division s Decision 768
19.8.1 T 243/87, »Active dry yeast/LESAFFRE«, EP B 8 554: Invalid Decision 768
19.8.2 T 939/91, »Culture of Bifidobacteria/NESTLE«, EP B1192 986: Invalid Decision . 768
19.8.3 T 960/94, »Incorrectly composed division/SYNGENE«, EP B1135 587 768
19.8.4 T 594/00, »Antimicrobial susceptibility testing/ALAMAR«, EP B1 454 784:
Substantial Procedural Violation 769
19.8.5 T 900/02, »Bordetellapertussis toxin/SCLAVO S.p.A.«, EP B1 322 533: Partiality,
Different Opposition Division Decided on Adaptation of the Description; Three
Years and Seven Months to Issue Written Decision; Such Grave Procedural
Deficiencies Lead to Invalidation of the Decision of the Opposition Division 770
19.8.6 T 315/03, »Transgenic animals/HARVARD«, EP B1169 672 771
19.8.7 T 343/01, »Omega 3 highly unsaturated fatty acids/MARTEK«, EP B1 512 997.... 771
19.8.8 T 654/04, »Phosphatidylserine/CHEMI«, EP B1 776 976 772
19.9 Opposition Proceedings: Miscellaneous 772
19.9.1 T 161/96, Underpayment of opposition fee/NOVO NORDISK«, EP B1 303 746:
Partial Payment of Opposition Fee 772
XXXIII
Contents
19.9.2 T 656/94, »Colony stimulating factor/KIRIN AMGEN«, EP B1237 545: Argu¬
ments of Others in Opposition Proceedings 772
19 9 3 G 3/99, »Admissibility of a joint opposition and appeal*, and T 272/95, »Relaxin/
HOWARD FLOREY INSTITUTE*, EP B1112149 773
19.9.4 G 1/97, »Request with a view to revision/ETA«, EP B1 98 239: Appeals Against
Decisions of Technical Boards 774
19.9.5 T 295/01, »Formalities officer duties/GLAXO«, EP B1 680 517, G 1/02, »Formal
ities officer s powers* • • • • 775
19.9.6 T 91/98, »Antiviral nucleosides/WELLCOME*, EP B1 306 597, and T 455/96,
»Blood substitute/BIOPURE CORPORATION*, EP B1277 289: Remittal to First
Instance 776
19.9.7 T 656/98, »Non partyappellant/GENENCOR«,EP Bl 260105: Transfer of patent
during appeal 776
19.9.8 T 224/99, »PDGF/ZYMOGENETICS«, EP B1177 957: Res Judicata 776
19.9.9 T 163/99, »Fatty acid esthers/UNILEVER*, EP B1383 404: Effect of Withdrawal of
All Claims 777
19.9.10 Tl 137/97, »Marek s Disease Virus Vaccine/AMERICAN HOME PRODUCTS
CORPORATION*, EP B1496135: Transfer of Opposition During Appeal, Late
Filed Document Admitted, Apportionment of Costs 777
19.9.11 T 8/01, »Chimeric chain receptors/CELL GENESYS*, EP B1 517 895:
Unsubstantiated Ground of Opposition 778
19.9.12 T 1126/00, »Platelet aggregationinhibitors/MILLENIUM«,EP Bl 477295: What
Happens if Both Patentee And Opponent Request Maintenance of a Patent in a
CertainForm? 779
19.9.13 T 475/01, »Phosphinotricine resistance gene/BAYER«, EP B1275 957: Procedural
Position of Non Professional Representatives and Substantiation of a Ground of
Appeal 779
19.9.14 T 716/01, »Bone resorption/WASHINGTON RESEARCH FOUNDATION*,
EP B1 502 928: Belated Withdrawal of Requests 780
19.9.15 T 1091/02, »Methods for detection/F. HOFFMANN LA ROCHE*, EP B1 520
794: Free Transfer of Opponent Status? 780
19.9.16 T 15/01, »Mystery swine disease/SDLO«, EP B1 587 780 780
20 Examples of Claims for a European Patent Application 781
21 Examples of Claims for a US Patent Application 783
21.1 Introduction 783
21.2 Claims Relating to Chemical Compounds 785
21.3 Claims Relating to DNA Sequences, Vectors, Plasmids, Host Cells, and Recombinant
DNAmolecules 785
21.4 Examples of Claims Relating to Polypeptides 787
21.5 Examples of Claims Relating to Microorganisms 787
21.6 Examples of Claims Relating to Monoclonal Antibodies 787
21.7 Examples of Claims Relating to Transgenic Plants and Animals 788
21.8 Method of Treatment Claims 789
21.9 Claims That Are Not Allowable In The U.S 790
22 Examples of Claims for a Japanese Patent Application 791
22.1 Introduction , 791
22.2 Claims Relating to Chemical Compounds 793
22.3 Claims Relating to DNA Sequences 793
22.4 Claims Relating to Recombinant Proteins 794
XXXIV
Contents
22.5 Claims Relating to Vectors and Transformants 796
22.6 Claims Relating to Microorganisms 796
22.7 Claims Relating to Monoclonal Antibodies 797
22.8 Claims Relating to Transgenic Plants 797
22.9 Claims Relating to Transgenic Animals 798
22.10 Claims Relating to Screening Methods 798
22.11 Claims Relating to Antagonists/Inhibitors or Agonists 798
22.12 Claims Relating to Pharmaceutical Inventions 799
23 How to Draft the Description of a European Patent Application 801
23.1 The Title of the Invention 801
23.2 The Indication of the Field of the Invention 801
23.3 The Acknowledgment of the Prior Art 801
23.4 The Technical Problem Underlying the Invention 801
23.5 The Solution 802
23.6 The Legends to the Figures 804
23.7 Examples 804
23.8 Sequence Listings 805
23.9 The Abstract 806
23.10 EASY 806
24 How to Draft the Description of a US Patent Application 809
24.1 The Elements of aU.S. Patent Application 809
24.1.1 Title of the Invention 809
24.1.2 Cross Reference to Related Applications 809
24.1.3 Background of the Invention 809
24.1.4 Summary of the Invention 810
24.1.5 Detailed Description of the Invention 810
24.1.6 Claims ¦ 813
24.1.7 Abstract 815
24.1.8 Sequence Listing 815
24.2 Meeting the Requirements of 35 U.S.C.§ 112, first paragraph 815
24.2.1 The Written Description Requirement 815
24.2.2 The Best Mode Requirement 819
25 How to Draft the Description of a Japanese Patent Application 823
25.1 Elements of a Japanese Patent Application 823
25.2 Title of the Invention 823
25.3 Technical Field 823
25.4 Prior Art 824
25.5 Problems to be Solved by the Invention 824
25.6 Means for Solving the Problems 824
25.7 Effects of the Invention 824
25.8 Mode for Carrying out the Invention 825
25.9 Examples 828
25.10 Sequence Listing 829
25.11 Abstract 829
26 How to Keep Notebooks for Successful Interferences 831
26.1 Record Keeping To Establish Dates Of Invention 831
26.2 Notebooks 832
XXXV
Contents
26.3 Electronic And Other Records Of Experiments 835
Decisions of the EPO 837
Decisions on U.S. Cases 855
Decisions on Japanese Cases 867
European Statutes 869
U.S. Statutes 871
Japanese Statutes 873
Index 875
XXXVI
|
| adam_txt |
Contents Summary
Page
Preface to the Fourth Edition V
Contributors to the Fourth Edition IX
Contents XIII
1 Patentable Subject Matter: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 1
2 Patentable Subject Matter: The EPO's Case Law 23
3 The Person Skilled in the Art: Legal Basis, Summary and Discussion of the EPO, US and
JPO Practice 49
4 The Person Skilled in the Art: The EPO's Case Law 55
5 Corrections and Amendments: Legal Basis, Summary and Discussion of the EPO, US and
JPO Practice 59
6 Corrections and Amendments: The EPO's Case Law 75
7 Clarity of Claims: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 131
8 Clarity of Claims: The EPO's CaseLaw 139
9 Enabling Disclosure: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 165
10 Enabling Disclosure: The EPO's Case Law 197
11 Deposit: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 295
12 Deposit: The EPO's Case Law 305
13 Priority: Legal Basis, Summary and Discussion ofthe EPO, US and JPO Practice 319
14 Priority: The EPO's Case Law 337
15 Novelty: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 369
16 Novelty: The EPO's Case Law 401
17 Inventive Step: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice . 505
18 Inventive Step: The EPO's Case Law 541
19 Decisions of the EPO Dealing with Procedural Issues 739
20 Examples of Claims for a European Patent Application 781
21 Examples of Claims for a US Patent Application 783
22 Examples of Claims for a Japanese Patent Application 791
23 How to Draft the Description of a European Patent Application 801
24 How to Draft the Description of a US Patent Application 809
25 How to Draft the Description of a Japanese Patent Application 823
26 How to Keep Notebooks for Successful Interferences 831
Decisions ofthe EPO 837
Decisions on U.S. Cases 855
Decisions on Japanese Cases 867
European Statutes 869
U.S. Statutes 871
Japanese Statutes 873
Index 875
XI
Contents
Page
Preface to the Fourth Edition V
1 Patentable Subject Matter: Legal Basis, Summary and Discussion of the EPO,
US and JPO Practice 1
1.1 Patentable Subject Matter: EPO (Art. 52(1) and (4) and Art. 53 EPC and the EU
Directive of July 6,1998 and its Implementation by the EPO) 1
1.2 Patentable Subject Matter: US (35 U.S.C. § 101 (1984)) 6
1.3 Patentable Subject Matter: JPO 16
2 Patentable Subject Matter: The EPO's Case Law 23
2.1 The Exclusion of Plant and Animal Varieties from Patent Protection in Consideration
of Article 53 EPC 23
2.1.1 Early case law on the exclusion of plant varieties T 49/83, »Propagating material/Ciba
Geigy«, EP A10 588, OJ EPO 1984,112, T 320/87, »Hybrid plants/Lubrizol«,
EP A 4 723, OJ EPO 1990,71 23
2.1.2 A step backwards: T 356/93, »Plant cells/PLANT GENETIC SYSTEMS*, OJ EPO
1995,545 24
2.1.3 An attempt of clarification: G 3/95,»Inadmissible referral*, OJEPO1996,169, and
conclusions 25
2.1.4 Reestablishment of patentability of transgenic plants in general terms: T 1054/96,
»Plants/NOVARTIS« and G 1/98, »Transgenic plant/NOVARTIS II«, OJ EPO
2000, 111 25
2.1.5 T 149/98, »Resistance development/BAYER«, EP B1 408 403 27
2.1.6 T 475/01, »Phosphinotricine resistance gene/BAYER«, EP B1275 957 . 27
2.1.7 How to apply Article 53 EPC in the patenting of transgenic animals: the pioneering
decisions T 19/90, »Onco mouse/HARVARD«, EP A 169 672, OJ EPO 1990,476,
and T 315/03, »Transgenic animals/HARVARD« 28
2.2 The Exclusion of »Essentially Biological Processes for the Production of Plants« from
Patent Protection: T 320/87, »Hybrid plants/Lubrizok, EP A 4 723,
OJEPO 1990,71 34
2.3 The Exclusion of »Essentially Biological Processes for the Production of Animals«
from Patent Protection: T 19/90, »Onco mouse/HARVARD«, EP A 169 672,
OJ EPO 1990,476 35
2.4 The Patenting of Human DNA is not Intrinsically Unethical: Opposition Division,
»Relaxin«, EP B1112 149, OJ EPO 1995,388, and T 272/95, »Relaxin/HOWARD
FLOREY INSTITUTE* 35
2.5 Compounds and Discoveries 36
2.5.1 DNA Sequences Isolated from Natural Sources Are no Discovery: Opposition Divi¬
sion, »Relaxin«, EP B1112 149, OJEPO 1995,388, andT 272/95, »Relaxin/
HOWARD FLOREYINSTITUTE« 36
2.5.2 Recombinant heterodimeric receptors are no discovery when industrially applicable:
T 338/00, »Multimeric receptors/SALK INSTITUTE*, EP B1 619 842 37
2.6 The Patenting of Pharmaceutical Inventions 38
XIII
Contents
2.7 The Patenting of Diagnostic Inventions and Screening Methods 43
2.7.1 T 1038/00, »Apoptotic cells/NEXINS RESEARCH*, EP B1 755 516 43
2.7.2 T 310/99, »Down Syndrome/MACRI«, EP B1409 956 43
2.8 Supplementary Protection Certificates (SPCs) for Pharmaceuticals and Plant
Protection Products 44
2.8.1 Introduction 44
2.8.2 Conditions for Obtaining a Certificate 44
2.8.3 Deadline for Applications 45
2.8.4 Documentation Required 45
2.8.5 Duration of the SPC 45
2.8.6 Problems regarding Licenses 45
2.8.7 The Scope of Protection of an SPC 46
3 The Person Skilled in the Art: Legal Basis, Summary and Discussion of the EPO,
US and JPO Practice 49
3.1 The Person Skilled in the Art: EPO 49
3.2 The Person Skilled in the Art: US 50
3.3 The Person Skilled in the Art: JPO 52
4 The Person Skilled in the Art: The EPO's Case Law 55
5 Corrections and Amendments: Legal Basis, Summary and Discussion of the EPO,
US and JPO Practice 59
5.1 Corrections and Amendments: EPO (Art. 123 and Rule 88 EPC) 59
5.2 Corrections and Amendments: US 64
5.3 Corrections and Amendments: JPO 68
6 Corrections and Amendments: The EPO's Case Law 75
6.1 T 184/91, »Glu Gln/CELTRIX«, EP A169 016, G 11/91, »Glu Gln/CELTRIX«,
EP A169 016; andT 1147/98, »Cartilage inducing factor/CELTRIX PHARMA¬
CEUTICALS INC.«,EP B1169016 75
6.2 T 161/86, »Amino acid sequence modification/ELI LILLY«, EP A 10 421 77
6.3 T 552/91, »Chroman derivatives/MERCK«, EP A 273 262 78
6.4 T 21/86, »Amendments/AMERICAN MONITOR CORP.«, EP A 9 222 79
6.5 T 365/88 improved vectors/BIOGEN«, EP A 41 767 79
6.6 T 449/90, »Treatment of plasma/CEDARS SINAI«, EP B 94 611 80
6.7 T 157/90, »Human calcitonin structural gene/CELL TECH«, EP A 70 675 81
6.8 T 923/92, »t PA/GENENTECH«, EP B193 619, OJ EPO 1996,564 83
6.9 T 749/94, »Erythropoietin/GENETICS INSTITUTE*, EP B1 209 539 86
6.10 T 379/95, »Hormones/ARS«, EP B1160 699 87
6.11 T 1046/96, »Pertussis/LELAND STANFORD*, EP B1275 689 88
6.12 T 277/95, »Production of erythropoietin/GENETICS INSTITUTE*,
EP B1 411 678 89
6.13 T 656/94, »Colony stimulatingfactor/KIRIN AMGEN«, EP B1 237 545 90
6.14 T 824/94, »LAV/INSTITUT PASTEUR«, EP B1178 978 90
6.15 T 138/95, »Intrapulmonary delivery/GENENTECH INC.«, EP B1257 956 92
6.16 T 985/95, »Treatment of infertility/NOVO NORDISK A/S«, EP B1 300 021 92
6.17 T 289/97, »Brassica/CALGENE«, EP B1270 615 93
6.18 T 354/97, »Protein secretion/GENENTECH*, EP B1 88 632 94
6.19 T 658/98, »Interferon beta 2A/YEDA RESEARCH*, EP A 645 542 95
XIV
Contents
6.20 T 588/95, »Chimera monoclonal antibody/RESEARCH DEVELOPMENT*,
EP B1171 496 96
6.21 T 188/97, »NANBV/Chiron Corporation*, EP B1318 216 96
6.22 T 1054/97, »Insect control/AVENTIS«, EP B1451 878 98
6.23 T 32/97, »Deleted tk PRV vaccines/NOVAGENE«, EP B1149 040 99
6.24 T 339/98, »Vitamin K dependent proteins/ELI LILLY«, EP B1 363 126 99
6.25 T 725/99, »Live vaccines/LELAND STANFORD JUNIOR UNIVERSITY*,
EP B1184 086 100
6.26 T 351/98, »HIV I/CHIRON CORPORATION*, EP B1181150 101
6.27 T 239/95, »Herpes simplex viral proteins/AMERICAN CYANAMID CO.«,
EP B1101 655 102
6.28 T 450/98, »BPI fragments/NEW YORK UNIVERSITY*, EP B1 375 724 . 103
6.29 T 93/98, »TNF inhibiting protein/BASF«, EP B1 471 701 103
6.30 T 1118/98,»Nucleicacids/DUPONTDENEMOURS«,EP B1520039 104
6.31 T 160/99, »Chlamydia/WASHINGTON«, EP Bl264 434 105
6.32 T 232/99, »Proteinproduction/ALUSUISSE HOLDINGS A.G.«,EP B1239 292 . 105
6.33 T 756/00, »Immunotherapy/CENTOCOR INC.«, EP A 755 683 106
6.34 T 346/01, »Osteoporosis/NOVARTIS«, EP A 560 723 106
6.35 T 216/96, »Process for amplifying, detecting and/or cloning nucleic acid sequences/
F. HOFFMANN LA ROCHE AG«, EP B1200 362 107
6.36 T 785/97, »Support bound oligonucleotides/OXFORD GENE TECHNOLOGY
LIMITED*, EP B1 386229 107
6.37 T 310/99, »Down Syndrome/MACRI«, EP B1409 956 108
6.38 T 944/99,»Pesticidaltoxins/MYCOGENCORPORATION*,EP B1 340948 . 109
6.39 T 279/00,»Asymmetric reductionprocess/AVECIA LTD.*, EP B1 658 211 109
6.40 T 502/00, »Determination of an analyte/DADE«, EP B1 492 499 110
6.41 T 608/00,»Transgenicbovine/PHARMING*,EP B1 502976 110
6.42 T 748/00, »Oligomer libraries/AFFYMAX*, EP B 1 604 552 Ill
6.43 T 1000/00, »Test device/ROCHE*, EP B1 654 659 112
6.44 T 1228/01, »Zona pelucida antigens/ZONAGEN INC.*, EP A 396 552 112
6.45 T 86/01, »Engineered bacteriophages/ACAMBIS*, EP B1 552 267 114
6.46 T 98/01, »Allergenicproteins/IMMULOGIC PHARMACEUTICAL
CORPORATION*, EP B1463 059 115
6.47 T 189/01, »IFN P2/IL 6R/YEDA RESEARCH AND DEVELOPMENT CO.,
LTD.«, EP B1413 908 115
6.48 T 1133/00, »Tumor suppression/UNIVERSITY OF CALIFORNIA*,
EP B1 475 623 116
6.49 T 286/01, »Humanised antibodies/CELLTECH THERAPEUTICS LTD.«,
EP B1460 167 116
6.50 T 345/01, »Cellulose degrading enzyme/NOVOZYMES«, EP B1 531 315 117
6.51 T 836/01, »Interferon beta2/YEDA RESEARCH AND DEVELOPMENT CO.
LTD.«, EP A 835 661 117
6.52 T 882/01'; »Protein expressionsystem/CELLTECH«, EP Bl 651 803 117
6.53 T 1014/01, »Recombinant immunoconjugates/BRISTOL MYERS SQUIBB CO.«,
EP Bl 439 095 118
6.54 T 1100/01, »Truncated transmembrane PACE/GENETICS«, EP Bl 574 402 119
6.55 T 1080/01, »Thermostableenzyme/F. HOFFMANN LA ROCHE*, EP Bl 258017 119
6.56 T 161/02, »Transgenic Zea mays plants/SYNGENTA«, EP Bl 513 849 120
6.57 T 579/01, »Cytoplasmic male sterile plants/ENZA ZADEN«, EP Bl 771 523 121
6.58 T 960/02, »Transfection/TRANSKARYOTIC THERAPIES*, EP Bl 649 464 122
6.59 T 1067/02, »Changed epitopes/NOVOZYMES«, EP Bl 561 907 123
6.60 T 157/03, »Reducing blood loss/ZYMOGENETICS«, EP Bl 624 095 124
6.61 T 1050/99, »Carbonyl hydrolases/GENENCOR«, EP Bl 251 446 125
XV
Contents
6.62 T 931/01, »Ribozyme/UNIVERSITY PATENTS*, EP B1291533 126
6.63 T 877/03, »Anti CD30 antibodies/ROCHE«, EP B1 805 871 126
6.64 T 626/00, »Framework mutated antibodies/WELLCOME«, EP B1 549 581 127
6.65 T 27/04, »Japanese hepatitis C virus/CHIRON«, EP B1419 182 129
6.66 T 20/04, »Flt3 ligands/SCHERING«, EP B1 699 236 129
6.67 T 1331/04, »MSF/GENETICS INSTITUTE*, EP A 567 599 130
7 Clarity of Claims: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 131
7.1 Clarity of Claims: EPO (Art. 84 EPC) 131
7.2 Clarity of Claims: US 134
7.3 Clarity of Claims: JPO 137
8 Clarity of Claims: The EPO's Case Law 139
8.1 T 301/87, »Alpha imerferons/BIOGEN«, EP B 32134, OJ EPO 1990,335 139
8.2 T 281/86, »Preprothaumatin/UNILEVER«, EP A 54 331, OJ EPO 1989,202 141
8.3 T 181/87, »DNA transfer vector/THE REGENTS OFTHE UNIVERSITY OF
CALIFORNIA*, EP A20 251 141
8.4 T 269/87, »Prochymosin/CELLTECH«, EP A 68 691 142
8.5 T 347/87, »Method of constructing a replicable cloning vehicle/GENENTECH«,
EP A22242 143
8.6 T 130/90 »Recombinant Monoclonal Antibody/UNIVERSITY OF TEXAS
SYSTEM*, EP B 68 763 144
8.7 T 391/91, »Ice nucleating/UNIVERSITY OF CALIFORNIA*, EP A 112 342 145
8.8 T 430/92, »Growthof tulips/SUMITOMO«,EP Bl 188 933 147
8.9 T 749/94, »Erythropoietin/GENETICS INSTITUTE*, EP B 1209 539 147
8.10 T 464/94, transformation of plant genetic material/NOVARTIS«, EP B1164 575 . 148
8.11 T 250/96, »Transformation/NOVARTIS«, EP A1429 093 149
8.12 T 277/95, »Production of erythropoietin/GENETICS INSTITUTE*,
EP B1 411 678 150
8.13 T 484/98, »Modified yeast/ELSWORTH«, EP A 463 024 150
8.14 T 965/98, »DNA amplification/HOFFMANN LA ROCHE«, EP A 509 612 151
8.15 T 966/98, »DNA detection/HOFFMANN LA ROCHE*, EP A 502 589 152
8.16 T 188/97, »NANBV/Chiron Corporation*, EP Bl 318 216 152
8.17 »Serotonin receptor/ELI LILLY*, EP A 449 562, OJ EPO 2001,103 153
8.18 T 1044/99, »Ionophoreantibiotics/UNGDA«,EP 615 544 153
8.19 T 680/98, improved vectors II/BIOGEN*, EP Bl 41 767 153
8.20 T 822/98, »Probes/BIO RAD«, EP Bl 246 864 154
8.21 T 239/95, »Herpes simplex viral proteins/AMERICAN CYANAMID CO.«,
EP Bl 101 655 155
8.22 T 64/00, »Insecticidal plant expression/MYCOGEN*, EP Bl 359 472 156
8.23 T 984/00, »Ti plasmid vectors/MAX PLANCK GESELLSCHAFT«,
EP A 290 799 157
8.24 T 1084/00, »HIV 3 variants/INNOGENETlCS*, EP Al 657 532 158
8.25 T 397/02, »Endogenous gene expression/APPLIED RESEARCH SYS«,
EP B 505 500 159
8.26 T 285/01, »Bone resorption/WASHINGTON RESEARCH FOUNDATION*,
EP Bl 394296 160
8.27 T 610/01, »Plant growth/LONG ASHTON RESEARCH STATION*,
EP A 703 983 160
8.28 T 347/02, »Neoplastic phenotype/UNIVERSITY OF CALIFORNIA*,
EP Bl 440 744 161
XVI
I Contents
]' 8.29 T 1074/00, »Hematopoietic growth factors/GENETICS INSTITUTE*,
\ EP B1314 705 161
' 9 Enabling Disclosure: Legal Basis, Summary and Discussion of the EPO, US and
JPO Practice 165
9.1 Enabling Disclosure: EPO (Art. 83 EPC) 165
9.2 Enabling Disclosure: US 173
9.3 Enabling Disclosure: JPO 189
10 Enabling Disclosure: TheEPO's Case Law 197
10.1 Decisions on enablement of nucleic acid and protein inventions 197
10.1.1 The Genentech polypeptide expression cases T 292/85 and T 794/94, EP B1 1 929 . 197
10.1.2 T 293/85, »Hybrid polypeptides/GENENTECH II«, EP A1 930 201
10.1.3 T 347/87, »Method of constructing a replicable cloning vehicle/GENENTECH«,
EP A 22 242 201
10.1.4 T 301/87, »Alpha interferons/BIOGEN«, EP B 32 134 202
10.1.5 T 281/86, »Preprothaumatin/UNILEVER«, EP A 54 331 202
! 10.1.6 T 283/86, »Bovinepre growthhormone/THE REGENTS OF THE UNIVERSITY
; OF CALIFORNIA*, EP A 47 600 203
i 10.1.7 Tl81/87,»DNAtransfervector/THEREGENTSOFTHEUNIVERSITYOF
CALIFORNIA*, EP A 20 251 204
10.1.8 T 772/89, »Bovine growth hormone/CASE WESTERN RESERVE
UNIVERSITY*, EP A 112 012 204
10.1.9 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 205
10.1.10 T 923/92, »t PA/GENENTECH«, EP B 193 619 • 210
10.1.11 T 128/92, »Interleukin 2/AJINOMOTO«, EP Bl 0 091 539 211
10.1.12 T 918/94, »Calcitonin/CELLTECH«, EP A 70 675 212
10.1.13 T 639/95, »Biopolymers/MIT«, EP A 329 770 213
10.1.14 T27/93,»Humannervegrowthfactor/GENENTECH«,EP B1121338 215
10.1.15 T 277/95, »Production of erythropoietin/GENETICS INSTITUTE*,
EP Bl 411 678 215
10.1.16 T 656/94, »Colony stimulating factor/KIRIN AMGEN«, EP Bl 237 545 216
10.1.17 T 493/94, »CSF/CHUGAI«, EP Bl 169 566 217
10.1.18 T 994/95, »01igonucleotide therapeutic agent/MOLECULAR BIOSYSTEMS*,
EP Bl 92 574 218
10.1.19 T 236/96, »Interleukin 1/DAINIPPON«, EP Bl 188 920 219
10.1.20 T 746/94, »Polypeptide isolation/BERLEX*, EP Bl 183 776 219
10.1.21 T 915/94, »Carbonyl hydrolases/GENENCOR INTERNATIONAL INC.«,
EP Bl 130 756 219
10.1.22 T 354/97, »Protein secretion/GENENTECH*, EP Bl 88 632 220
10.1.23 T 743/97,»Thrombolyticproteins/GENETICSINSTITUTE*,EP Bl293394 . 220
10.1.24 T 1055/97, »Drug delivery conjugates/EN2O«, EP Bl 285 950 221
10.1.25 T 838/97, »Translationalinhibition/RESEARCH FOUNDATION*,
EP Bl 140 308 222
10.1.26 T 749/98, »Cellulase/NOVOZYMES A/S«, EP Bl 531 372 ._ 223
101.27 T216/96, »Process for amplifying, detecting and/or cloning nucleic acid sequences/
F. HOFFMANN LA ROCHE AG«, EP Bl 200 362 224
10.1.28 T 280/00, »Inhibin/GENENTECH«, EP Bl 222 491 226
10.1.29 T 620/99, »Homologous recombination/CELL GENESIS INC.«, EP Bl 452 484 . 227
10.1.30 T 58/00, »Hepatic growth factor/MITSUBISHI«, EP Bl 412 557 228
10.1.31 T 15/00, »Serum albumin/DELTA BIOTECH*, EP Bl 386 222 229
10.1.32 T 731/00, »Cleansingproteins/OCTAPHARMA«, EP Bl 484 464 230
XVII
Contents
10.1.33 T 748/00, »Oligomer libraries/AFFYMAX«, EP B1 604 552 231
10.1.34 T 787/00, »Erythropoietin/AMGEN«, EP B1428 267 231
10.1.35 T 397/02, »Endogenous gene expression/APPLIED RESEARCH SYS«,
EP B 505 500 234
10.1.36 T 351/01, »Tissue factor protein/GENENTECH«,EP Bl 278 776 235
10.1.37 T 811/01, »IL 1 inhibitor/BIOGEN«, EP B1341273 236
10.1.38 T 1120/01, »Cell surface antigen/OSAKA BIOSCIENCE«; EP A 510 691 237
10.1.39 T 1080/01, »Thermostableenzyme/F. HOFFMANN LA ROCHE«,EP B1258 017 237
10.1.40 T 1074/00, »Hematopoietic growth factors/GENETICS INSTITUTE*,
EP B1 314 705 238
10.1.41 T 1067/02, »Changed epitopes/NOVOZYMES«, EP B1 561 907 239
10.1.42 T 1093/02, »Nucleic acids probes/GEN PROBE INC.«, EP A 272 009 240
10.1.43 T 558/03, Wild type p53 gene/JOHNS HOPKINS UNIVERSITY*, EP B 1390323 241
10.2 Decisions on enablement of antibody technology inventions 241
10.2.1 T 299/86, »Monoclonal anti ot IFN antibody/SECHER«, EP A 50 129, OJ EPO
1988,88 241
10.2.2 Examining Division, »Deposit number/ROCKEFELLER«, EP 86 90 2639.3 242
10.2.3 The Ortho monoclonal antibody cases 243
10.2.4 T 431/96, »Monoclonal antibody/AGEN«, EP B1122 478 246
10.2.5 T 669/97, »Chimeric antibodies/CELLTECH THERAPEUTICS LTD«,
EP B1194 276 247
10.2.6 T 400/97, »Immunoglobulins/CELLTECH«, EP B1120 694 248
10.2.7 T 1212/97, »Immunoglobulin preparations/GENENTECH«, EP B1125 023 250
10.2.8 T 310/99, »Down Syndrome/MACRI«, EP B1409 956 250
10.2.9 T 505/00, »Anti free PSA antibody/LILJA«, EP B1 540 573 251
10.2.10 T 792/00, »Varied binding proteins/DYAX«, EP B1 436 597 252
10.2.11 T 619/01, »Immunotoxins/RESEARCH DEVELOPMENT FOUNDATION«,
EP A1 634 938 253
10.2.12 T 877/03, »Anti CD30 antibodies/ROCHE«, EP B1 805 871 253
10.2.13 T 626/00, »Framework mutated antibodies/WELLCOME«, EP B1 549 581 254
10.3 Decisions on enablement of plant inventions 255
10.3.1 T 612/92, »Monocotyledonous plants/RIJKSUNIVERSITEIT LEIDEN«,
EP B1159 418 255
10.3.2 T 694/92, »Modifyingplant cells/MYCOGEN«, EP B1122 791 256
10.3.3 T 1052/98, »Gene switch/SYNGENTA«, EP A 455 667 258
10.3.4 T 149/98, »Resistance development/Bayer«, EP B1 408 403 258
10.3.5 T 984/00, »Ti plasmid vectors/MAX PLANCK GESELLSCHAFT«,
EP A 290 799 259
10.3.6 T 78/01, »Insect resistant plants/MYCOGEN«, EP B1142 924 259
10.3.7 T 1120/00, »Soybean desaturase/DU PONT«, EP B1 537178 260
10.3.8 T 610/01, »Plant growth/LONG ASHTON RESEARCH STATION*,
EP A 703 983 261
10.3.9 T 891/02, »Potatostarch/BASF«, EP A 563 201 261
10.3.10 T 579/01, »Cytoplasmic male sterile plants/ENZA 2ADEN«, EP B1 771 523 261
10.3.11 T 1006/02, »Selection of transformed cells/SYNGENTA«, EP B1 601 092 262
10.3.12 T 550/03, »Epigenetic regulation/STERNHEIMER«, EP A 648 275 262
10.4 Decisions on enablement of inventions concerning viruses and their epitopes 263
10.4.1 T 449/90, »Treatment of plasma/CEDARS SINAI«, EP B 94 611 263
10.4.2 T 886/91, »Hepatitis B virus/BIOGEN«, EP B113 828 264
10.4.3 T 187/93, »Vaccines/GENENTECH«, EP B1139 417 265
10.4.4 T 824/94, »LAV/INSTITUT PASTEUR«, EP B1178 978 266
10.4.5 T 188/97, »NANBV/Chiron Corporation*, EP B1 318 216 267
10.4.6 T 32/97, »Deleted tk PRV vaccines/NOVAGENE«, EP B1149 040 269
XVIII
, Contents
10.4.7 T 351/98, »HIV I/CHIRON CORPORATION*, EP B1181150 270
10.4.8 T 239/95, »Herpes simplex viral proteins/AMERICAN CYANAMID CO.«,
EP B1101655 271
/ 10.4.9 T 552/00, »3D MPL/SMITHKLINE«, EP B1 689 454 : . 272
10.4.10 T 839/01, »Non A/non B hepatitis virus/GENELABS TECHNOLOGIES*,
EP A419 576 272
10.4.11 T 857/01, »Herpes simplex virus/GENERAL HOSPITAL*, EP B1 453 242 273
10.4.12 T 127/02,»Herpesvirusmutantsstromalkeratitis/HARVARD«,EP A739414 . 273
10.4.13 T 15/01, »Mystery swine disease/SDLO«, EP Bl 587 780 .¦ 274
10.5 Decisions on enablement of inventions concerning microorganisms 275
10.5.1 T 740/90, »Active dry yeast/LESAFFRE«, EP B 8 554 .; 275
10.5.2 T 48/85, »Coccidiosis vaccines/NRDC«, EP A 47 662 276
10.5.3 T 242/92, »Invasivephenotype/STANFORD«, EP A211 543 278
10.5.4 T 780/95, »Antigenicpreparations/EVANSMEDICAL«, EP Bl 162 639 279
10.5.5 T 727/95, »Cellulose/WEYERSHAEUSER«, EP Bl 228 779 280
10.5.6 T 446/99, »Bordetella toxin/AMGEN«, EP Bl 306 318 282
10.5.7 T 36/00, »Proteinase deficient fungi/GENENCOR*, EP Bl 429 490 282
10.6 Decisions on enablement of other inventions 283
10.6.1 T 19/90, »Onco mouse/HARVARD«, EP A 169 672 283
10.6.2 T 383/94, »Aminooxydase/UNDERBERG«, EP Bl 170 880 284
10.6.3 T 289/96, »Detecting sequences/ZENECA«, EP Bl 332 435 284
10.6.4 T 985/95, »Treatment of infertility/NOVO NORDISK A/S«, EP Bl 300 021 . 285
10.6.5 T 455/96, »Blood substitute/BIOPURE CORPORATION*, EP Bl 277289 285
10.6.6 T 148/98, »Blood substitutes/BAXTER BIOTECH TECHNOLOGY*,
EP Bl 358 708 285
10.6.7 T 944/99, »Pesticidal toxins/MYCOGEN CORPORATION*, EP Bl 340 948 . 286
10.6.8 T 222/00, »Hemicellulose degradation/VALTION«, EP B 1 545 958 286
10.6.9 T 285/01, »Bone resorption/WASHINGTON RESEARCH FOUNDATION*,
EP Bl 394 296 287
10.6.10 T 537/02, »Detergent composition/UNILEVER*, EP Bl 563 103 287
10.6.11 T 609/02, »AP 1 complex/SALK INSTITUTE*, EP Bl 552 202 288
10.6.12 T 716/01, »Bone resorption/WASHINGTON RESEARCH FOUNDATION*,
EP Bl 502 928 290
10.6.13 T 1127/02, »Soluble and insoluble form of an antigen/CONNAUGHT*,
EP Bl 588 578 291
10.6.14 T 157/03, »Reducing blood loss/2YMOGENETICS«, EP Bl 624 095 291
10.6.15 T 729/00, »Screeningmethod/HOUSEY*, EP Bl 403 506 292
10.6.16 T 669/04, »CED 3 inhibitors/MIT«, EP A 672151 293
11 Deposit: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 295
11.1 Deposit: EPO (Art. 83 EPC and Rule 28 of the Implementing Regulations) 295
11.2 Deposit: US 298
11.3 Deposit: JPO 301
12 Deposit: The EPO's Case Law 305
12.1 T 361/87, »Microorganisms/NABISCO«, EP A 97 973 305
12.2 T 39/88, »Microorganisms/CPC«, EP A 111 683 305
12.3 T 106/88, »Microorganisms/CPC«, EP A 112 459; T 90/88, »Microorganism/
MICROLIFE*, EP A 76 953; T 239/87, »Microorganisms/NABISCO«,
EP A 98 533; T 142/93, »Antibiotics/AMERICAN CYANAMID*, EP A 182152 . 306
12.4 T 118/87, »Amylolytic enzymes/CPC«, EP A 34 470 306
12.5 J 8/87J 9/87, »Submitting culture deposit information/IDAHO«, EP A 155 476 . 307
XIX
Contents
12.6 Examining Division, »Deposit number/ROCKEFELLER«, EP 86 90 2639.3 307
12.7 T 815/90, »Hepatitis Avirus/UMTED STATES OF AMERICA*, EP A196 316,
G 2/93, »Sufficiency of disclo sure/Culture deposit information 308
12.8 T 886/91, »Hepatitis B virus/BIOGEN«, EP B113 828 311
12.9 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 311
12.10 T 923/92, »t PA/GENENTECH«, EP B163 619 312
12.11 T 128/92, »Interleukin 2/AJINOMOTO«, EP B1 0 091 539 313
12.12 T 227/97, »Protein Rib/LINDAHL«, EP A 656 014 313
12.13 T 1147/01, »PRRS Vaccine/AKZO NOBEL N.V.«, EP B1 610 250 313
12.14 Questions and Answers Addressing Some Practical Problems of Deposits for
European Patent Applications and PCT Applications Designating the EPO 314
12.14.1 Does Rule 28(2) of the Implementing Regulations require submission of information
in a specific form? 314
12.14.2 Can availability of the deposited microorganism to third parties be terminated by
deleting deposit information from the published PCT application when it is moved to
the EP stage? 314
12.14.3 How are the limitations under Rule 28(3) influenced by refusal or withdrawal of an
application or expiration of a patent term? 315
12.14.4 What penalties will be imposed on a person who uses the microorganism obtained
from the depositary for non experimental purposes? 315
12.14.5 For the purposes of Rule 28(4), when are the technical preparations for publication of
the application completed? 315
12.14.6 Is an expert under Rule 28(5) permitted to pass the microorganism on to the party
requesting the deposited culture? 316
12.14.7 Does use of the expert solution system conflict with German Patent Law? 316
12.14.8 How is the expert solution option indicated in the Article 93 publication of a
European application? 317
12.14.9 What are the requirements if the applicant and the depositor are not the same person 317
13 Priority: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 319
13.1 Priority: EPO (Arts. 87 to 89 EPC) 319
13.2 Priority: US 323
13.3 Priority: JPO 334
14 Priority: The EPO's Case Law 337
14.1 T 81/87, »Preprorennin/COLLABORATIVE«, EP A 57 350, OJ EPO 1990,250 . 337
14.2 T 269/87, »Prochymosin/CELLTECH«, EP A 68 691 338
14.3 T 301/87, »Alpha interferons/BIOGEN«, EP B 32134, OJ EPO 1990,335 339
14.4 T 886/91, »Hepatitis B virus/BIOGEN«, EP B113 828 339
14.5 T 296/93, »HBV antigen production/BIOGEN«, EP B1182 442, OJ EPO 1995,627 340
14.6 T 65/92, »HTLV/HARVARD COLLEGE*, EP A 151579 341
14.7 T207/94,»Fibroblastinterferon/BIOGEN«,EP B141313 342
14.8 T 441/93, »Cloning in Kluyveromyces/GIST BROCADES«, EP B1 96 430 343
14.9 T 413/94, »Human GM CSF/IMMUNEX CORP.«, EP B1183 350 344
14.10 T 380/94, »Insectcontrol/PGS«,EP Bl 193259 345
14.11 T 277/95 »Production of erythropoietin/GENETICS INSTITUTE*,
EP B1411678 346
14.12 T 236/96, »Interleukin 1/DAINIPPON«, EP B1188 920 347
14.13 T 919/93, »Heat treated factor VIII/CEDARS SINAI«, EP B1 94 611 348
14.14 T 51/95, »Mature leukocyte interferons/HOFFMANN LA ROCHE«,
EP B1211148 348
14.15 T 1112/96, »Erythropoietinproduction/GENETICS INSTITUTE*, EP B1205 564 348
XX
Contents
14.16 T 542/95, »TNF/YEDA«,EP B1186 833 349
14.17 T 1147/98, »Cartilage inducing factor/CELTRIX PHARMACEUTICALS INC.«,
EP B1169016 350
14.18 T 188/97, »NANBV/Chiron Corporations EP B1 318 216 350
14.19 T 479/97, »Expression system/NOVARTIS«, EP B1 353 188 351
14.20 T 351/98, »HIV I/CHIRON CORPORATION*, EP B1181150 352
14.21 T 342/98, »A. orizae/NOVOZYME, EP B1 238 023 353
14.22 T 93/98, »TNF inhibiting protein/BASF«, EP B1471 701 354
14.23 T 1099/99, »Filamentous fungi/GENENCOR*, EP B1215 594 355
14.24 T 216/96, »Process for amplifying, detecting and/or cloning nucleic acid sequences/
F.HOFFMANN LA ROCHE AG«,EP B1200 362 356
14.25 T 785/97, »Support bound oligonucleotides/OXFORD GENE TECHNOLOGY
LIMITED*, EP B1386 229 357
14.26 T 280/00, »Inhibin/GENENTECH«, EP B1222 491 357
14.27 T 120/00, »Mycobacteria/COGENT«, EP B1460 041 357
14.28 T 279/00, »Asymmetric reductionprocess/AVECIA LTD.«, EP B1 658 211 358
14.29 T 356/00, »Mammary gland FIX intron construct/PPL«, EP B1 396 699 359
14.30 T 552/00, »3D MPL/SMITHKLINE«, EP B1 689 454 360
14.31 T 1127/00, »Ribozymes/GENE SHEARS«, EP B1 321 201 360
14.32 T 8/01, »Chimeric chain receptors/CELL GENESYS«, EP B1 517 895 361
14.33 T 351/01, »Tissue factor protein/GENENTECH«, EP B1278 776 361
14.34 T 423/01, »Lengthpolymorphisms/MAX PLANCK GESELLSCHAFT«,
EP B1 438 512 362
14.35 T 486/01, »IGF 1/GENENTECH, INC.«, EP B1597 033 363
14.36 T 1014/01, »Recombinant immunoconjugates/BRISTOL MYERS SQUIBB CO.«,
EP B1 439 095 364
14.37 T 1080/01,»Thermostableenzyme/F.HOFFMANNLAROCHE«,EP B1258017 364
14.38 T 1074/00, »Hematopoietic growth factors/GENETICS INSTITUTE*,
EP B1 314 705 365
14.39 T 843/03, »Human papillomavirus/THE UNIVERSITY OF ROCHESTER*,
EP A 688 227 366
14.40 T 15/01, »Mystery swine disease/SDLO«, EP B1 587 780 366
14.41 T 20/04, »Flt3 ligands/SCHERING«, EP B1 699 236 368
15 Novelty: Legal Basis, Summary and Discussion of the EPO, US and JPO Practice 369
15.1 Novelty: EPO (Art. 54 EPC) 369
15.2 Novelty:US 382
15.3 Novelty:JPO 393
16 Novelty: The EPO's Case Law 401
16.1 Decisions on Novelty for Protein Inventions 401
16.1.1 T 877/90, »T cell growth factor/HOOPER«, EP B 49 611 401
16.1.2 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 402
16.1.3 T 187/93, »Vaccines/GENENTECH«, EP B1139 417 404
16.1.4 T 367/95, »Antihemophilic factor/PHARMACIA«, EP B1197 901 404
16.1.5 T 656/94,»Colony stimulating factor/KIRIN AMGEN«, EP B1237 545 405
16.1.6 T 493/94, »CSF/CHUGAI«, EP B1169 566 406
16.1.7 T 51/95, »Mature leukocyte interferons/HOFFMANN LA ROCHE«,
EP B1211148 407
16.1.8 T 767/95, »Interleukin l/IMMUNEX CORPORATION*, EP B1165 654 407
16.1.9 T 1147/98,»Cartilage inducing factor/CELTRIX PHARMACEUTICALS INC.«,
EP B1169 016 • 407
XXI
Contents
16110 T 378/95, »Factor VIIIC/CHIRON*, EP B1150 735 408
16.1.11 T 1208/97, »Analogs/AMGEN«, EP B1309 565 408
16.1.12 T 479/97, »Expression system/NOVARTIS«, EP B1 353 188 409
16.1.13 T 429/96, »Serine protease inhibitors/AMGEN*, EP B1205 555 409
16.1.14 T 450/98, »BPI fragments/NEW YORK UNIVERSITY*, EP B1 375 724 410
16.1.15 T 93/98, »TNF inhibiting protein/BASF«, EP B1 471 701 410
16.1.16 T 944/99,»Pesticidaltoxins/MYCOGENCORPORATIONSEP B1340948 . 411
16.1.17 T 58/00, »Hepatic growth factor/MITSUBISHI«, EP B1412 557 411
16.1.18 T 1072/00, »Borreliaburgdorferi/MIKROGEN«, EP B1 506 868 411
16.1.19 T 787/00, »Erythropoietin/AMGEN«, EP B1 428 267 412
16.1.20 T 610/01, »Plant growth/LONG ASHTON RESEARCH STATION*,
EP A 703 983 412
16.1.21 T 836/01, »Interferon beta2/YEDA RESEARCH AND DEVELOPMENT CO.
LTD.«, EP A 835 661 413
16.1.22 T 1120/01, »Cell surface antigen/OSAKA BIOSCIENCE*; EP A 510 691 413
16.1.23 T 1080/01, "Thermostable enzyme/F. HOFFMANN LA ROCHE«, EP B1258 017 414
16.1.24 T 458/02, »Hydrolized collagen/STOESS AG«, EP A 777 491 415
16.1.25 T 537/02, »Detergent composition/UNILEVER«, EP B1 563 103 415
16.1.26 T 734/00, »Novel Borrelia vaccine/SYMBICOM AB«, EP A 711 563 416
16.1.27 T 1127/02, »Soluble and insoluble form of an antigen/CONNAUGHT«,
EP B1588 578 416
16.1.28 T 1201/02, »Heparanase/INSIGHT STRATEGY*, EP A 998 569 416
16.1.29 T 93/03, »Lymphotoxin/GENENTECH«, EP A 768 889 417
16.1.30 T 157/03, »Reducing blood loss/ZYMOGENETICS«, EP B1 624 095 418
16.1.31 T 90/03, »Phytase/BASF«, EP A 779 037 418
16.2 Decisions on Novelty for DNA Sequence Inventions 419
16.2.1 T 53/87, »Mitochondrial DNA/HOECHST AG«, EP A 66 249 419
16.2.2 T 301/87, »Alpha interferons/BIOGEN«, EP B 32134, OJ EPO 1990,335 419
16.2.4 Opposition Division, »Relaxin« and T 272/95, »Relaxin/HOWARD FLOREY
INSTITUTE*, EP B1112149, OJ EPO 1995,388 420
16.2.5 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 421
16.2.6 T 128/92, »Interleukin 2/AJINOMOTO«, EP B10 091539 421
16.2.7 T 236/96, »Interleukin 1/DAINIPPON«, EP B1188 920 422
16.2.8 T 1112/96, »Erythropoietinproduction/GENETICS INSTITUTE*, EP B 1205 564 422
16.2.9 T 838/97, »Translationalinhibition/RESEARCH FOUNDATION*,
EP B1140308 . 423
16.2.10 T 280/00, »Inhibin/GENENTECH«, EP B1222 491 424
16.2.11 Tll20/00,»Soybeandesaturase/DUPONT«,EP B1537178 424
16.2.12 T 423/01, »Lengthpolymorphisms/MAX PLANCK GESELLSCHAFT«,
EP B1438 512 426
16.2.13 T 340/00, »Thermostable enzyme/F. HOFFMANN LA ROCHE*, EP B1395 736 426
16.2.14 T 656/03, »Factor VIII/BIOVITRUM*, EP Bl 506 757 427
16.3 Decisions on Novelty of Inventions Relating to Systems for the Expression of DNA
Sequences 428
16.3.1 T 158/91, »Human growth hormone/GENENTECH*, EP A'l27'305 428
16.3.2 T 782/91, »Expressing a gene/KYOWA«, EP Bl 88 166 430
16.3.3 T207/94,»Fibroblastinterferon/BIOGEN*,EP Bl41 313,OJEPO1999,273 . 431
16.3.4 T901/94,»Methodofimprovingyields/CETUSONCOLOGY«,EP Bl 156 355 . 432
16.3.5 T916/94,»Refractileprotein/GENENTECH«,EP B1114 506 432
16.3.6 T 277/95, »Production of erythropoietin/GENETlCS INSTITUTE*,
EP Bl 411 678 \ 433
16.3.7 T 746/94,»Polypeptideisolation/BERLEX*,EP Bl 183 776 434
16.3.8 T 745/96, » Animal cell culture/ALUSUISSE HOLDINGS A.G.«, EP Bl 229 809. 434
XXII
Contents
16.3.9 T 354/97, »Proteinsecretion/GENENTECH«, EP Bl 88 632 435
16.3.10 T 1099/99, »Filamentous fungi/GENENCOR«, EP Bl 215 594 435
16.3.11 T 1092/98, transformed cells/ZYMOGENETICS«, EP Bl 171142. 436
16.3.12 T 356/00, »Mammary gland FIX intron construct/PPL«, EP Bl 396 699 436
16.3.13 T 15/00, »Serum albumin/DELTABIOTECH«, EP Bl 386 222 437
16.3.14 T 100/01, »Variantproteins/GENENTECH, INC.«, EP Bl 564 531 437
16.3.15 T 522/99, »Human parvovirus B19 proteins/RIJKSUNIVERSITEIT LEIDEN«,
EP Bl 491 824 438
16.3.16 T 882/01, »Protein expression system/CELLTECH«, EP Bl 651 803 438
16.3.17 T 199/02, »Targeted destruction of neoplastic cells/THE GENERAL HOSPITAL
CORPORATIONS EP Bl 476 953 439
16.3.18 T 729/99, »Homologous recombination/INSTITUTPASTEUR«, EP Bl 419 621 . 440
16.4 Decisions on Novelty for Plasmid Inventions 441
16.4.1 T 109/91, »Compositeplasmid/AJINOMOTO«, EP B 93 611 441
16.4.2 T 576/91, »Plasmid pTR2030/NORTH CAROLINA STATE«, EP A 208 468 443
16.4.3 T 339/93, »Recombinant vaccinia virus/HEALTHRESEARCH*, EP Bl 83 286 . 444
16.5 Decisions on Novelty for Inventions on Antibody Technology 445
16.5.1 T 3/89, »Determination of antigens/AKZO«, EP A 45 103 . 445
16.5.2 T 130/90, »Recombinant monoclonal antibody/UNIVERSITY OF TEXAS
SYSTEM«, EP B 68 763 446
16.5.3 T 431/96, »Monoclonal antibody/AGEN«, EP Bl 122 478 446
16.5.4 T 542/95,»TNF/YEDA«,EP Bl 186833 446
16.5.5 »Radiolabelled antibodies/RHOMED INC.«, EP Bl 234 612 447
16.5.6 T 669/97, »Chimeric antibodies/CELLTECH THERAPEUTICS LTD«,
EP Bl 194276 447
16.5.7 T 400/97, »Immunoglobulins/CELLTECH«, EP Bl 120 694 447
16.5.8 T 1212/97, »Immunoglobulin preparations/GENENTECH«, EP Bl 125 023 449
16.5.9 T 735/00, »Anti CRP antibodies/IATRONLABORATORIES, INC.«, EP Bl 431
171 451
16.5.10 T 1014/01, »Recombinant immunoconjugates/BRISTOL MYERS SQUIBB CO.«,
EP Bl 439 095 452
16.5.11 T 877/03, »Anti CD30 antibodies/ROCHE«, EP Bl 805 871 453
16.5.12 T 626/00, »Framework mutated antibodies/WELLCOME«, EP Bl 549 581 453
16.6 Decisions on Novelty for Plant Inventions 453
16.6.1 T 612/92, »Monocotyledonous plants/RIJKSUNIVERSITEIT LEIDEN«,
EP Bl 159418 453
16.6.2 T 951/93, »Chamomile drug/ROBUGEN«, EP 89 10 3429.0 454
16.6.3 T 387/94, »Chimeric genes/MONSANTO«, EP Bl 131 623 455
16.6.4 T 464/94, »Transformation of plant genetic material/NOVARTIS«, EP Bl 164 575 . 456
16.6.5 T 741/94, »Parasite resistance/DUKE«, EP A 215 907 457
16.6.6 T 1054/97, »Insect control/AVENTIS«, EP Bl 451 878 458
16.6.7 T 149/98, »Resistance development/Bayer«, EP Bl 408 403 458
16.6.8 T 579/01, »Cytoplasmic male sterile plants/ENZA ZADEN«, EP Bl 771 523 459
16.6.9 T 1006/02, »Selection of transformed cells/SYNGENTA«, EP Bl 601 092 459
16.6.10 T 1026/02, »Oilseed brassica/PIONEER HI BRED INTERNAT.«, INC.«,
EP A 891130 460
16.6.11 T 890/02, »Chimeric gene/BAYER«, EP A 828 837 460
16.7 Viruses and Their Epitopes 461
16.7.1 T 886/91, »Hepatitis B virus/BIOGEN«, EP Bl 13 828 461
16.7.2 T 815/90 »Hepatitis A virus/UNITED STATES OF AMERICA*, EP A 196 316 . 462
16.7.3 T 977/93, »Canine coronavirus vaccine/AMERICAN HOME PRODUCTS CO.«,
EP B 1145 783, OJ EPO 2001,84 462
16.7.4 T 383/97, »Hepatitis C virus/ROCHE«, EP A 564 532 464
XXIII
Contents
16.7.5 T 351/98, »HIV I/CHIRON CORPORATION*, EP B1181150 465
16.7.8 Tl 137/97, »Marek's Disease Virus Vaccine/AMERICAN HOME PRODUCTS
CORPORATION*, EP B1496135 465
16.7.9 T 108/98, »HSV glycoproteins/DADE BEHRING«, EP B1 139 416 466
16.7.10 T 583/03, »Human packaging cell line/CHIRON«, EP A 854193 467
16.7.11 T 451/99, »AIDS related disease/BIO RAD LABS.«, EP B1220 273 467
16.7.12 T 10/01, »AIDS polypeptides/GENENTECH«, EP B1187 041 469
16.7.13 T 15/01, »Mystery swine disease/SDLO«, EP Bl 587 780 469
16.8 PCR and Other in vitro Nucleic Acid Amplification and Detection Methods 470
16.8.1 Opposition Division, »PCR/Hoffmann La Roche« (December 14,1995),
EP B1201184, and the Technical Board's later decision T 78/96, »Process for
amplifying nucleic acid sequences/F. HOFFMANN LA ROCHE AG« 470
16.8.2 T 216/96, »Process for amplifying, detecting and/or cloning nucleic acid sequences/
F. HOFFMANN LA ROCHE AG«,EP B1200 362 473
16.8.3 T 902/94, »DNA amplification/BAYLOR COLLEGE OF MEDICINE*,
EP A 364 255 474
16.9 Microorganisms and How to Modify Them 475
16.9.1 T 70/85, »Microbial transformation/SHELL«, EP A 54 987 475
16.9.2 T 78/95, »Penicilliumchrysogenum/ANTIBIOTICOS«,EP Bl 235 951 476
16.9.3 T 295/96, »Gene amplification/GIST BROCADES*, EP B1284126 476
16.9.4 T 430/96, »Aspergillus/GIST BROCADES N.V.«, EP B1184 438 477
16.9.5 T 36/00, »Proteinase deficient fungi/GENENCOR«, EP B1 429 490 478
16.9.6 T 1070/00, »Antibiotic clustered genes/DSM«, EP B1 357119 478
16.10 Other Decisions onNovelty 479
16.10.1 G 1/92, »Availability to the public*, OJ EPO1993,277 479
16.10.2 T 657/92, »Microorganisms/MYCOGEN«, EP A 200 344 480
16.10.3 T 645/90, »Fermentedmilkproducts/MICROLIFE*, EP B1 0 111 020 482
16.10.4 T 879/94, »Human G CSF/CHUGAI*, EP B1 217 404 482
16.10.5 T 131/95, »01igonucleoside/JOHNS HOPKINS*, EP A 266 099 483
16.10.6 T 919/93, »Heat treated factor VIII/CEDARS SINAI*, EP Bl 94 611 483
16.10.7 T 744/97, »Detectionofmicrobes/EDBERG,S.«, EP Bl 254 771 484
16.10.8 T 71/95, »Immunoassay/AMERSHAM INTERNATIONAL plc«, EP Bl 324 540. 485
16.10.9 T 138/95, »Intrapulmonary delivery/GENENTECH INC.*, EP Bl 257 956 485
\ 16.10.10 T 985/95, »Treatment of infertility/NOVO NORDISK A/S«, EP Bl 300 021 485
16.10.11 T 466/96»Biocatalyst/KLEIN«, EP Bl 173 915 485
16.10.12 T 867/97, »Proteinhydrolysates/NOVARTIS«, EP Bl 421 309 486
16.10.13 T 800/99, »Cancer therapy/SIDNEY KIMMEL CANCER CENTER*,
EP A 758 382 487
16.10.14 T 989/98»Antigenicconjugates/OHIO«,EP B662839 487
16.10.15 T 247/97, »Augmentation materials from the placenta/INSTITUT CLAYTON DE
LARECHERCHE*, EP Bl 285 370 488
16.10.16 T 269/97, »Composition for treating insufficiency of the pancreas/SHARP]i«,
EP Bl 387 945 488
16.10.17 T 291/97, »Hormones/PROTHERICS MOLECULAR DESIGN LIMITED*
EP A293530 489
16.10.18 T 795/98, »Biologicalprocess/aktieselskabetfaxekalkbrud«, EP Bl 461166 489
16.10.19 T 295/99, »Glucose 6 Phosphate/IATRON«, EP Bl 469154 490
16.10.20 T 669/01, »Growthhormone/PHARMACIA AB«, EP A 707 491 491
16.10.21 T 343/00, »Creamyeast/DSMN.V.«, EP Bl 461 725 491
16.10.22 T 785/97, »Support bound oligonucleotides/OXFORD GENE TECHNOLOGY
LIMITED*, EP Bl 386 229 492
16.10.23 T310/99,»DownSyndrome/MACRI*,EP Bl409956 492
XXIV
Contents
16.10.24 T 919/99, »Neonatal hematopoietic stem cells/PHARMASTEM
THERAPEUTICS*, EP B1 343 217 492
16.10.25 T 505/00, »Anti free PSA antibody/LILJA«, EP B1 540 573 493
16.10.26 T 552/00, »3D MPL/SMITHKLINE«, EP B1689 454 493
16.10.27 T 676/00, »Cell culture medium/CHIRON«, EP B1 435 911 494
16.10.28 T 846/00, »Thrombus detection/ANTISOMA LIMITED«, EP B1429 626 494
16.10.29 T 635/00, »Hybridisation sandwich/BIO MERIEUX«, EP B1486 661 495
16.10.30 T 737/00, »Sweetener/SUDZUCKER«, EP B1 625 578 495
16.10.31 T 1076/00, »Vaccine against drugs/CHILKA Ltd.«, EP B1496 839 496
16.10.32 T 1127/00, »Ribozymes/GENE SHEARS*, EP B1 321201 497
16.10.33 T 166/01,»Invitromethod/KAROBIOAB«,EP B1 607268 498
16.10.34 T 881/01, »Alpha amylase reagent/MODROVICH I.E.«, EP B1 568 959 498
16.10.35 T 1028/01, »Immunoglobuline solutions/OCTAPHARMA«, EP B1 525 502 499
16.10.36 T 812/02, »Microanalysis of samples on disc/REMACLE«, EP A 1 044 375 500
16.10.37 T 870/02, »Transmembrane potentials/REGENTS CALIFORNIA*,
EP B1 834 074 500
16.10.38 T 1090/02, »Luciferase/PROMEGA«, EP B1 553 234 501
16.10.39 T 729/00, »Screening method/HOUSEY«, EP B1 403 506 502
16.10.40 T 1092/01, »Lutein/INDUSTRIAL ORGANICA«, EP B1 741 795 502
16.10.41 T 509/04, »Cerebralpalsy/ALLERGAN«, EP B1 605 501 503
17 Inventive Step: Legal Basis, Summary and Discussion of the EPO, US and JPO
Practice 505
17.1 Inventive Step: EPO (Art. 56 EPC) 505
17.2 Inventive Step: US 517
17.3 Inventive Step: JPO 530
18 Inventive Step: The EPO's Case Law 541
18.1 Decisions on Inventive Step for Protein Inventions (Including Inventions Relating to
Methods for the Preparation of Proteins and their Use) 541
18.1.1 T 419/87, »Single cell protein material/PHILLIPS PETROLEUM COMPANY*,
EP B 17 853 541
18.1.2 T 249/88, »Milkproduction/MONSANTO«, EP A 85 036 542
18.1.3 T 877/90, »T cell growth factor/HOOPER*, EP B 49 611 543
18.1.4 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 543
18.1.5 T 379/94, »Treatmentof leukaemias/SCHERING*, EP B1 276120 544
18.1.6 T 758/94, »Subtilisin analogs/AMGEN«, EP B1 254 735 545
18.1.7 T 187/93, »Vaccines/GENENTECH« (March 5,1997), EP B1139 417 546
18.1.8 T 202/95, »Alpha h ANP/FUJISAWA«, EP Bl 206 769 546
18.1.9 T 656/94,»Colony stimulatingfactor/KIRIN AMGEN*, EP Bl 237545 547
18.1.10 T 493/94, »CSF/CHUGAI«, EP Bl 169 566 547
18.1.11 T 51/95, »Mature leukocyte interferons/HOFFMANN LA ROCHE«,
EP Bl 211148 548
18.1.12 T 223/96, »Protein C/ELI LILLY*, EP Bl 191 606 548
18.1.13 T 767/95, »Interleukin l/IMMUNEX CORPORATION*, EP Bl 165 654 549
18.1.14 T 743/97, »Thrombolyticproteins/GENETlCS INSTITUTE*, EP Bl 293 394 . 550
18.1.15 T 1147/98, »Cartilage inducingfactor/CELTRIXPHARMACEUTICALS INC.*,
EP Bl 169 016 551
18.1.16 T 378/95, »Factor VIIIC/CHIRON«, EP Bl 150 735 551
18.1.17 T 1208/97, »Analogs/AMGEN«, EP Bl 309 565 551
18.1.18 T 429/96, »Serineproteaseinhibitors/AMGEN«, EP Bl 205 555 552
18.1.19 T 749/98, »Cellulase/NOVOZYMES A/S«, EP Bl 531372 552
XXV
Contents ——
18.1.20 T 450/98, »BPI fragments/NEW YORK UNIVERSITY*, EP B1 375 724 553
18 121 T 465/98, »Haemophilus pleuropneomoniae/CENTRAAL DIERGENEESKUN
DIGINSTITUUT«,EP B1354628 553
18 1 22 T 750/98,»Outer membrane protein/CYANAMID«, EP B1 449 958 554
18.1.23 T 338/00, »Multimeric receptors/SALK INSTITUTE*, EP B1 619 842 554
18 1 24 T 446/99, »Bordetella toxin/AMGEN«, EP B1306 318 556
18.1.25 T 944/99, »Pesticidal toxins/MYCOGEN CORPORATION*, EP B1 340 948 . 557
18.1.26 T 58/00, »Hepatic growth factor/MITSUBISHI*, EP B1 412 557 557
18.1.27 T 1072/00, »Borrelia burgdorferi/MIKROGEN«, EP B1 506 868 557
18.1.28 T 787/00, »Erythropoietin/AMGEN«, EP B1428 267 558
18.1.29 T 189/01, »IFN P2/IL 6R/YEDA RESEARCH AND DEVELOPMENT CO.,
LTD.«,EP B1413 908 558
18.1.30 T 210/01, »IL 4 mutant proteins/BAYER«, EP B1 613 499 559
18.1.31 T 493/01, »Acellularvaccine/CELLTECH«, EP B1 573 435 559
18.1.32 T 486/01, »IGF 1/GENENTECH, INC.«, EP B1597 033 560
18.1.33 T 610/01, »Plantgrowth/LONG ASHTON RESEARCH STATION*,
EP A 703 983 560
18.1.34 T 1037/01, »Factor VIII/IMMUNO«, EP B1 567 448 560
18.1.35 T 1080/01,»Thermostableenzyme/EHOFFMANNLAROCHE«,EP B1258017 561
18.1.36 T 458/02, »Hydrolized collagen/STOESS AG«, EP A 777 491 561
18.1.37 T 537/02, »Detergent composition/UNILEVER*, EP B1 563 103 562
18.1.38 T 734/00, »NovelBorreliavaccine/SYMBICOM AB«, EP A 711563 562
18.1.39 T 889/02, »Membrane cofactor protein/WASHINGTON UNIVERSITY*,
EP A 483 247 562
" 18.1.40 T 986/02, »Anticytokine/YEDA«, EP A 512 528 563
18.1.41 T 1127/02, »Soluble and insoluble form of an antigen/CONNAUGHT*,
EP B1 588 578 564
18.1.42 T 93/03, »Lymphotoxin/GENENTECH«, EP A 768 889 564
18.1.43 T 157/03, »Reducing blood loss/ZYMO GENETICS*, EP B1 624 095 564
18.1.44 T 999/03, »CD protein/STATE UNIVERSITY OF NEW YORK«, EP A 737 085 . 565
18.1.45 T 292/01, »Plasmaproteins/CENTRE REGIONAL DE TRANSFUSION SAN¬
GUINE DELILLE«,EP B1 359593 565
18.2 Decisions on Inventive Step for DNA Sequence Inventions 567
18.2.1 T 301/87, »Alpha interferons/BIOGEN«, EP B 32 134, OJ EPO1990,335 567
18.2.2 T 500/91 »Alpha interferons II/BIOGEN«, EP B 32134 567
18.2.3 T 223/92, »Human y interferon/GENENTECH«, EP B 77 670 569
18.2.4 T 816/90, »CBH II/ALKO*, EP A 214 971 571
18.2.5 T 412/93, »Erythropoietin/AMGEN«, EP B1148 605 572
18.2.6 T 923/92, »t PA/GENENTECH«, EP B 193 619 574
18.2.7 T 128/92, »Interleukin 2/AJINOMOTO«, EP B1 0 091 539 576
18.2.8 T 495/92, »Gln' interferonvariant/CANCER INSTITUTE*, EP B1112 976, and
T 510/92, »Novel human interferon y polypeptide/KYOWA HAKKO*,
EP B1121157 . 577
18.2.9 T 386/94, »Chymosin/UNILEVER«, EP B1 77 109, OJ EPO 1996,658 578
18.2.10 T530/95,»XmaI/NEWENGLANDBIOLABS«,EP B1395 367 581
18.2.11 T 475/93, »IGF II/CHIRON«, EP B1189 481 582
18.2.12 T 656/94, »Colony stimulating factor/KIRIN AMGEN«, EP B1237 545 583
18.2.13 T 70/95, »Enhancer/HOECHST«, EP A1173 177 584
18.2.14 T 236/96, »Interleukin 1/DAINIPPON«, EP B1188 920 585
18.2.15 T 1092/96, »Interferon beta2A/YEDA RESEARCH*, EP B1220 574 585
18.2.16 T 223/96, »Protein C/ELI LILLY*, EP B1191606 586
18.2.17 T 1112/96, »Erythropoietinproduction/GENETICS INSTITUTE*,EP B 1205 564 587
XXVI
Contents
18.2.18 T 915/94, »Carbonyl hydrolases/GENENCOR INTERNATIONAL INC.«,
EP B1 130 756 587
18.2.19 T 637/97, »Bindingprotein/GENENTECH«, EP B1406 272 588
18.2.20 T 838/97, »Translational inhibition/RESEARCH FOUNDATION*,
EP B1140 308 589
18.2.21 T 479/97, »Expression system/NOVARTIS«, EP B1353 188 590
18.2.22 T 111/00, »Monokine/FARBER«, EP A 679186 590
18.2.23 T 343/98, »Fibroblast growth factor/THE SALK INSTITUTE FOR
BIOLOGICAL STUDIES*, EP B1228 449 591
18.2.24 T 272/95, »Relaxin/HOWARD FLOREY INSTITUTE*, EP B 1,112149 592
18.2.25 T 29/99, »Serine protease inhibitors/AMGEN«, EP Bl205 475 592
18.2.26 T 3/00, »Protease/SHIONOGI«, EP B1482 879 594
18.2.27 T 280/00, »Inhibin/GENENTECH«, EP B1222 491 594
18.2.28 T 8/01, »Chimeric chain receptors/CELL GENESYS«, EP B1 517 895 595
18.2.29 T 150/03, »Channelproteins/CHIBA UNIVERSITY*, EP A1 768 379 596
18.2.30 T 182/03, »Phosphodiesterase/SMITHKLINE BEECHAM«, EP A1 752 853 596
18.2.31 Tl 133/00, »Tumor suppression/UNIVERSITY OF CALIFORNIA*,
EP B1 475 623 597
18.2.32 T 351/01, »Tissue factor protein/GENENTECH«, EP B1278 776 597
18.2.33 T 423/01, »Lengthpolymorphisms/MAX PLANCK GESELLSCHAFT«,
EP B1438 512 597
18.2.34 T 1120/01, »Cell surface antigen/OSAKABIOSCIENCE«; EP A 510 691 598
18.2.35 T 875/02, »Microbial phytase/BASF«, EP B 1 420 358 598
18.2.36 T 340/00, »Thermostable enzyme/F. HOFFMANN LA ROCHE*, EP B1395 736 599
18.2.37 T 1074/00, »Hematopoietic growth factors/GENETICS INSTITUTE*,
EP B1 314 705 600
18.2.38 T 1093/02,»Nucleicacidsprobes/GEN PROBEINC.*,EP A272009 600
18.2.39 T 1201/02, »Heparanase/INSIGHT STRATEGY*, EP A 998 569 601
18.2.40 T 769/03, »Ileal bile acid transporter/WAKE FORREST UNIVERSITY*,
EP A 737 075 601
18.2.41 T 656/03, »Factor VIII/BIOVITRUM*, EP Bl 506 757 602
18.3 Decisions on Inventive Step of Inventions Relating to Systems for the Expression of
DNASequences 602
18.3.1 T 60/89, »Fusionproteins/HARVARD«, EP B 6 694 603
18.3.2 T 717/89, »Hepatitis B virus E antigens/BIOGEN*, EP A 75 395 603
18.3.3 T 455/91,»Expressionofpolypeptidesinyeast/GENENTECH«,EP Bl 60057 . 604
18.3.4 T 782/91,»Expressingagene/KYOWA«,EP Bl 88 166 607
18.3.5 T 880/92 »Factor IX/TRANSGENE«, EP Bl 162 782 607
18.3.6 T 844/93, »Hepatitis B surface antigen invertebrate cell culture/GENENTECH«,
EP Bl 73 656 608
18.3.7 T 845/93, »Hepatitis B antigen in yeast/GENENTECH«, EP Bl 73 657 609
18.3.8 T 207/94,«Fibroblast interferon/BIOGEN*, EP Bl 41 313, OJ EPO 1999,273 610
18.3.9 T 413/94, »Human GM CSF/IMMUNEX CORP.*, EP Bl 183 350 612
18.3.10 T 901/94, »Method of improving yields/CETUS ONCOLOGY*, EP B 156 355 . 613
18.3.11 T916/94,»Refractileprotein/GENENTECH«,EP B1114 506 613
18.3.12 T 67/95, »Parvovirus capsids/THE UNITED STATES OF AMERICA*,
EP A1441897 614
18.3.13 T 277/95, »Production of erythropoietin/GENETICS INSTITUTE*,
EP Bl 411 678 .' 615
18.3.14 T 746/94, »Polypeptide isolation/BERLEX«, EP Bl 183 776 615
18.3.15 T 745/96, »Animal cell culture/ALUSUISSE HOLDINGS A.G.«, EP Bl 229 809. 615
18.3.16 T 791/96, »Pseudorabies/UPJOHN«, EP Bl 223 382; 617
18.3.17 T 680/98, improved vectors II/BIOGEN*, EP Bl 41 767 618
XXVII
Contents _^_
18.3.18 T 342/98, »A. orizae/NOVOZYME, EP B1238 023 618
18 3 19 T 224/99, »PDGF/ZYMOGENETICS«, EP B1177 957; 619
18.3.20 T 294/99, »Cysteine free peptides/TAKEDA LTD.«, EP B1 499 990 620
18.3.21 T 1099/99, »Filamentous fungi/GENENCOR«, EP B1215 594 621
18.3.22 T 747/01, »Filamentous fungi/DSM«, EP A1 768 383 621
18.3.23 T 1092/98, .Transformed cells/ZYMOGENETICS«, EP B1171142 622
18.3.24 T 620/99, »Homologous recombination/CELL GENESIS INC.«, EP B1 452 484 . 622
18.3.25 T 356/00, »Mammary gland FIX intron construct/PPL«, EP B1 396 699 623
18.3.26 T 15/00, »Serum albumin/DELTA BIOTECH«, EP B1 386 222 624
18.3.27 T 100/01,»Variant proteins/GENENTECH, INC.«, EP B1 564 531 625
18.3.28 T 522/99, »Human parvovirus B19 proteins/RIJKSUNIVERSITElT LEIDEN«,
EP B1491 824 625
18.3.29 T 473/01, »Neorotransmitter uptake/BAYLOR COLLEGE*, EP B1 502 845 626
18.3.30 T 627/01, »Secretion of proteins/GENENTECH, INC«, EP B1 88 632 626
18.3.31 T 1059/01, »Human DNase/GENENTECH«, EP B1449 968 626
18.3.32 T 1102/00, »Mammalian membrane receptors/CNRS«, EP B1 344 024 627
18.3.33 T 199/02, »Targeted destruction of neoplastic cells/THE GENERAL HOSPITAL
CORPORATION*, EP B1476 953 627
18.3.34 T 893/02, »GP75/SLOAN KETTERING«, EP B1522 078 627
18.3.35 T 960/02, »Transfection/TRANSKARYOTIC THERAPIES*, EP B1649 464 628
18.3.36 T 729/99, »Homologous recombination/INSTITUT PASTEUR*, EP B1 419 621 . 629
18.4 Decisions on Inventive Step for Plasmid Inventions 630
18.4.1 T 162/86, »Plasmid pSG2/HOECHST AG«, EP A 66 701, OJ EPO 1988,452 630
18.4.2 T 264/87, »Yeast transformant/ANVAR«, EP B 11 562 630
18.4.3 T 347/87, »Method of constructing a replicable cloning vehicle/GENENTECH*,
EP A 22 242 630
18.4.4 T 609/90, »Protecting bacteria/ELI LILLY*, EP A 105 608 630
18.4.5 T 339/93, »Recombinant vaccinia virus/HEALTH RESEARCH*, EP B1 83 286 . 631
18.5 Decisions on Inventive Step for Inventions on Antibody Technology 633
18.5.1 T 499/88, »Immunoglobulins/UNILEVER«, EP A 59 598 633
18.5.2 T 36/90, »Tumor cells/BOGOCH«, EP A 676 642 634
18.5.3 T 683/90, »Tumor localization/GOLDENBERG*, EP B 35 265 634
18.5.4 T 906/91, »Monoclonal antibody to theophylline/DuPont*, EP B1 98 179 636
18.5.5 T 915/93, »Monoclonal antibody therapy/ORTHO*, EP A 222 617 640
18.5.6 T 355/92, »anti FSH antibody/BOEHRINGERMANNHEIM*, EP A 193 880 . 641
18.5.7 T 478/92, »anti LH antibody/BOEHRINGER MANNHEIM*, EP A 193 881 . 642
! 18.5.8 T 63/94, »Determinationofantigens/AKZONOBEL«,EP Bl 45103 642
18.5.9 T 958/93, »Quantitation of immunoglobulins/WAKO«, EP B1161 638 642
18.5.10 T 510/94, »Monoclonal antibody OKT5/ORTHO* (April 21,1998), EP B125 722 . 643
18.5.11 T 512/94, »Monoclonal antibody/ORTHO«, EP B1 30 815 644
18.5.12 T 513/94, »Monoclonal antibody (OKT3)/ORTHO«, EP B118 795 644
18.5.13 T 431/96, »Monoclonal antibody/AGEN«, EP B1122 478 644
18.5.14 T 457/95, »Immunoassay/ABBOTT LABORATORIES*, EP B1160 900 645
18.5.15 T 542/95,»TNF/YEDA«,EP B1186833 645
18.5.16 T 606/96, »Radiolabelled antibodies/RHOMED INC.*, EP B1 234 612 646
18.5.17 T 669/97, »Chimeric antibodies/CELLTECH THERAPEUTICS LTD*,
EP B1194276 646
18.5.18 T 1212/97,»Immunoglobulinpreparations/GENENTECH«,EP B1125023 . 646
18.5.19 T 753/00, »Production of proteins/B.R. CENTRE LIMITED*, EP B1 542 810 . 647
18.5.20 T 886/00, »Immunoglobulin variable domain sequences/MEDICAL RESEARCH
COUNCIL*, EP B1 368 684 648
18.5.21 T 735/00, »Anti CRP antibodies/IATRON LABORATORIES, INC.*,
EP B1431171 649
XXVIII
Contents
18.5.22 T 1014/01, »Recombinantimmunoconjugates/BRISTOL MYERS SQUIBB CO.«,
EP B1 439 095 650
18.5.23 T 645/02, »Antibodies/EBERHARD KARLS UNIVERSITAT«, EP A 787 743 . 651
18.5.24 T 278/03,»Antibody production/WELLCOME«, EP Bl 481 790 651
18.5.25 T 877/03, »Anti CD30 antibodies/ROCHE«, EP Bl 805 871 653
18.5.26 T 626/00, »Framework mutated antibodies/WELLCOME*, EP B1 549 581 654
18.6 Decisions on Inventive Step for Plant Inventions 655
18.6.1 T 694/92, »Modifying plant cells/MYCOGEN«, EP B1122 791 655
18.6.2 T 13/93, »Plant growth regulator/UNION OIL«, EP B1241 568 655
18.6.3 T 387/94, »Chimeric genes/MONSANTO«, EP B1 131 623 656
18.6.4 T 380/94, »Insect control/PGS«, EP B1193 259 658
18.6.5 T 425/96, »Tomato plants/MONSANTO«, EP Bl269 601 659
18.6.6 T 1051/96, »Genetic linkages/PIONEER«, EP A 402 401 659
18.6.7 T 303/95, »Chimeric gene/RH6NE POULENC«, EP A 337 899 660
18.6.8 T 338/97, »Molecular farming/CALGENE INC.«, EP B1233 915 661
18.6.9 T 1054/97, »Insects control/AVENTIS«, EP B1451 878 663
18.6.10 T 215/96, »Plant breeding/S G SEEDS B.V.«, EP B1361124 664
18.6.11 T 333/97, »Somatic changes/MONSANTO«, EP 0 223 399 665
18.6.12 T 1148/00, »Seed material/OYPANIMOLABORATORIO«, EP A 6778 120 667
18.6.13 T 1115/97, »Herbicide resistance in plants/MGIPHARMA,INC.«,EP Bl 154204 667
18.6.14 T 149/98, »Resistance development/Bayer«, EP B1 408 403 668
18.6.15 T 984/00, »Ti plasmid vectors/MAX PLANCK GESELLSCHAFT«,
EP A 290 799 669
18.6.16 T 475/01, »Phosphinotricine resistance gene/BAYER«,EP Bl 275 957 669
18.6.17 T 1198/01,»Vaccinesexpressedinplants/PRODIGENE,INC.«,EP A728014. 669
18.6.18 T 579/01, »Cytoplasmic male sterile plants/ENZA ZADEN«, EP B1 771 523 670
18.6.19 T 1006/02, »Selection of transformed cells/SYNGENTA«, EP B1 601 092 670
18.6.20 T 890/02, »Chimeric gene/BAYER«, EP A 828 837 671
18.7 Viruses and Their Epitopes 672
18.7.1 T 261/89, »Human hepatitis Avirus/MERCK«, EP B 25 745 672
18.7.2 T 886/91, »HepatitisBvirus/BIOGEN«, EP Bl 13 828 672
18.7.3 T 296/93, »HBVantigen production/BIOGEN«, EP B1182 442 675
18.7.4 T 279/96, »Retrovirases/WHITEHEAD INSTITUTE*, EP A1432 216 676
18.7.5 T 145/95, »Newcastle disease virus/BTG«, EP B1227 414 677
18.7.6 T 977/93, »Canine coronavirus vaccine/AMERICAN HOME PRODUCTS CO.«,
EP B 1145 783 680
18.7.7 T 372/97, »Newcastle disease virus vaccine/YISSUM RESEARCH*, EP B 1292 293 680
18.7.8 T 448/96, »Virus free antihemophilic factor/CRTSL«, EP B1 343 275 681
18.7.9 T 188/97, »NANBV/Chiron Corporation*, EP B1 318 216 682
18.7.10 T 32/97, »Deleted tk PRV vaccines/NOVAGENE«, EP B1149 040 682
18.7.11 T 91/98, »Antiviral nucleosides/WELLCOME«, EP Bl 306 597 683
18.7.12 T 351/98, »HIV I/CHIRON CORPORATION*, EP Bl 181150 685
18.7.13 T 228/01, »Carcinoembryonic antigen/US GOVERNMENT*, EP A 584 266 686
18.7.14 T 239/95, »Herpes simplex viral proteins/AMERICAN CYANAMID CO.«,
EP Bl 101 655 687
18.7.15 T 108/98, »HSV glycoproteins/DADE BEHRING«, EP Bl 139 416 687
18.7.16 T 747/98, »HTLV III peptides/ORTHO«, EP Bl 261224 688
18.7.17 T 1097/99, »HIVpeptides/ADALTIS INC.*, EP Bl 326 490 688
18.7.18 T 1147/01,»PRRSvaccine/AKZONOBELN.V.«,EP B1610250 689
18.7.19 T 127/02, »Herpesvirus mutants stromal keratitis/HARVARD*, EP A 739 414 . 690
18.7.20 T 454/03, »Viral vector/TRANSGENE*, EP Bl 742 834 690
18.7.21 T 451/99, »AIDS related disease/BIO RAD LABS.*, EP Bl 220 273 691
18.7.22 T 968/00, »Retroviral vectors/CELL GENESYS*, EP B 1 556 345 692
XXIX
Contents
18.7.23 T 15/01, »Mystery swine disease/SDLO«, EP Bl 587 780 692
18 8 PCR and Other in vitro Nucleic Acid Amplification and Detection Methods 693
18.8.1 T 289/96, »Detecting sequences/ZENECA«, EP B1 332 435 693
18 8.2 T 965/98, »DNA amplification/HOFFMANN LA ROCHE«, EP A 509 612 693
18.8.3 T 1118/98,»Nucleicacids/DUPONTDENEMOURS«,EP B1520039 694
18.8.4 T 78/96, »Process for amplifying nucleic acid sequences/E HOFFMANN LA
ROCHEAG«,EP B1201184 694
18.8.5 T 216/96, »Process for amplifying, detecting and/or cloning nucleic acid sequences/
F.HOFFMANN LA ROCHE AG«,EP B1200 362 695
18.8.6 T 749/00»Polynucleotide probes/ENZO BIOCHEM, INC.« (March 19,2003),
EP A1 525 821 6%
18.8.7 T 302/02, » Automated amplification/APPLERA«, EP B1236 069 697
18.9 Microorganisms and How to Modify Them 698
18.9.1 T 391/91, »Ice nucleating/UNIVERSITY OF CALIFORNIA*, EP A 112 342 698
18.9.2 T 441/93, »Cloning in Kluyveromyces/GIST BROCADES*, EP B1 96 430 698
18.9.3 T 78/95, »Penicillium chrysogenum/ANTIBIOTICOS*, EP Bl235 951 699
18.9.4 T 430/96, »Aspergillus/GIST BROCADES N.V.«, EP B1184 438 699
18.9.5 T 737/96, »Astaxanthin/DSM«,EP Bl 367765 700
18.9.6 T 630/92, »Salmonellavaccines/LELAND STANFORD JUNIOR UNIVER
SITY«,EP A 184086 701
18.9.7 T 36/00, »Proteinase deficient fungi/GENENCOR«, EP B1 429 490 702
18.10 Other Decisions onlnventive Step 703
18.10.1 T 148/88, »Watersoluble Peptides/PFRIMMER«, EP B 87 751 703
18.10.2 T 181/88, » Assaying reagent/UNITIKA«, EP A 89210 704
18.10.3 T 645/90, »Fermented milk products/MICROLIFE«, EP B1 0 111 020 705
18.10.4 T 137/92, immobilized lipase/NOVO«, EP B1140 542 705
18.10.5 T 698/93, »Amine removal/CPC«, EP B1132 674 705
18.10.6 T 850/92, »Glutamine di and tripeptides/PHARMACIA«, EP B1220 379 706
18.10.7 T 847/94, »Sterilization/ELOPAK SYSTEMS AG«, EP 89 30 4519.5 706
18.10.8 T 856/94, »Cell grafting/UNIVERSITY OF CALIFORNIA*, EP A 449 948 707
18.10.9 T 599/94, »Cultivating milk/ARLA«, EP B1 154 614 708
18.10.10 T 455/95, »Enzyme composition/CPI«, EP B1219 269 709
18.10.11 T 138/95, »Intrapulmonary delivery/GENENTECH INC.«, EP Bl 257 956 710
18.10.12 T 985/95,»Treatmentof infertility/NOVONORDISK A/S«,EP Bl 300021 711
18.10.13 T 466/96, »Biocatalyst/KLEIN«, EP Bl 173 915 711
18.10.14 T 867/97, »Protein hydrolysates/NOVARTIS«, EP Bl 421 309 711
18.10.15 T 966/98, »DNA detection/HOFFMANN LA ROCHE«, EP A 502 589 712
18.10.16 T 422/96, »Method for detecting an analyte/ENZO BIOCHEM«, EP Bl 212 670 . 712
18.10.17 T 800/99, »Cancer therapy/SIDNEY KIMMEL CANCER CENTER«,
EP A 758 382 713
18.10.18 T 1044/99, »Ionophore antibiotics, EP A 615 544 !.!.!!!"!!!!!!!!!!"!!!!! 714
18.10.19 T 666/95, »Agent for the therapy of hemophilia A/AVENTIS BEHRING GMBH«,
EP Bl 255 651 715
18.10.20 T 911/95, »Medicinal composition^ RESEARCH, EP Bl 270 545 . 715
18.10.21 T 339/98, »Vitamin K dependent proteins/ELI LILLY«, EP Bl 363 126 .715
18.10.22 T 1045/98, »Eosinophilia/SCHERING«, EP Bl 367 596 716
18.10.23 T 704/01»Vaccineagainstcholesterol/ENTREMED«,EP A562020 . 717
18.10.24 T 455/96, »Blood substitute/BIOPURE CORPORATION*, EP Bl 277 289 718
18.10.25 T 247/97, »Augmentation materials from the placenta/INSTITUT CLAYTON DE
LA RECHERCHE*, EP Bl 285 370 718
18.10.26 T 251/97, »Factor XIII/HOECHST JAPAN LIMITED*, EP Bl 278 416 '. 718
18.10.27 T 782/97, detecting agent/YALE UNIVERSITY*, EP Bl 149 654 719
XXX
Contents
18.10.28 T 795/98, »Biological process/AKTIESELSKABET FAXE KALKBRUD«,
EP B1 461166 720
18.10.29 T 919/93, »Heat treated factor VIII/CEDARS SINAI«, EP Bl 94 611 720
18.10.30 T 295/99, »Glucose 6 Phosphate/IATRON«, EP B1 469 154 721
18.10.31 T 343/00, »Cream yeast/DSM N.V.«, EP B1 461 725 721
18.10.32 T 785/97, »Support bound oligonucleotides/OXFORD GENE TECHNOLOGY
LIMITED*, EP B1 386 229 722
18.10.33 T 187/99, »Assay method/ORTHO«, EP B1149 565 722
18.10.34 T 310/99, »DownSyndrome/MACRI«, EP Bl 409 956 723
18.10.35 T 1038/00, »Apoptotic cells/NEXINS RESEARCH*, EP B1 755 516 723
18.10.36 T 505/00, »Anti free PSA antibody/LILJA«, EP B1 540 573 ., 724
18.10.37 T 552/00, »3D MPL/SMITHKLINE«, EP B1 689 454 724
18.10.38 T 676/00, »Cell culture medium/CHIRON«, EP B1435 911 725
18.10.39 T 731/00,»Cleansing proteins/OCTAPHARMA«, EP B1 484 464 725
18.10.40 T 748/00, »Oligomerlibraries/AFFYMAX«, EP B1 604 552 726
18.10.41 T 635/00, »Hybridisation sandwich/BIO MERIEUX«, EP B1486 661 726
18.10.42 T 737/00, »Sweetener/SUDZUCKER«, EP Bl 625 578 727
18.10.43 T 1076/00, »Vaccine againstdrugs/CHILKA Ltd.«, EP Bl 496 839 727
18.10.44 T 1127/00, »Ribozymes/GENE SHEARS*, EP Bl 321201 727
18.10.45 T 182/00»IgE response/SCHERING«, EP Bl 327 283 729
18.10.46 T 728/99, »Factor VIII/IMMUNO AG«, EP Bl 496 723 729
18.10.47 T1101/00,»Bloodcoagulationdisorders/DAHLBACK«,EP Bl 608235 730
18.10.48 T 166/01, »In vitro method/KARO BIO AB«, EP Bl 607 268 730
18.10.49 T 285/01, »Bone resorption/WASHINGTON RESEARCH FOUNDATION*,
EP Bl 394 296 730
18.10.50 T 881/01, »Alpha amylase reagent/MODROVICH I.E.«, EP Bl 568 959 731
18.10.51 T 1024/01, isolation of nucleic acid/AKZO«, EP Bl 389 063 731
18.10.52 T 1028/01, »Immunoglobuline solutions/OCTAPHARMA«, EP Bl 525 502 732
18.10.53 T 1091/01, »Human c peptide/TOSOH«, EP Bl 484 961 732
18.10.54 T 812/02, »Microanalysis of samples on disc/REMACLE«, EP A1 044 375 733
18.10.55 T 699/02, »Fibrinogen solution/AVENTIS BEHRING GmbH«, EP A 554 570 . 733
18.10.56 T 870/02, »Transmembranepotentials/REGENTS CALIFORNIA*,
EP Bl 834 074 734
18.10.57 T 1090/02, »Luciferase/PROMEGA«, EP Bl 553 234 734
18.10.58 T 543/04, »Appetite suppressant/CSIR«, EP A 973 534 734
18.10.59 T 505/03, Conjugated linoleic acid/LODERS CROKLAAN*, EP Bl 866 874 . 735
18.10.60 T 729/00, »Screening method/HOUSEY*, EP Bl 403 506 735
18.10.61 T 250/02, »Pharmaceutical compositions/NITSAS*, EP Bl 835 120 736
18.10.62 T 940/02, »Use of a peptide/NOVO NORDISK A/S«, EP Bl 631 505 737
18.10.63 T 509/04, »Cerebral palsy/ALLERGAN«, EP Bl 605 501 737
19 Decisions of the EPO Dealing with Procedural Issues 739
19.1 Substantive Examination: General 739
19.1.1 T 283/88, »Plasminogenactivator/ABBOT«, EP A 37 687: Denial of Interview . 739
19.1.2 T 800/90, »Hemophilia/QUEEN S UNIVERSITY*, EP A 129 998: Rejection of
Application Without Warning 740
19.1.3 T 188/92, »Grounds for appeal/BEECHAM*, EP A 207 589: Inadmissible Appeal . 741
19.1.4 T 299/86, »Monoclonal anti a IFN antibody/SECHER«, EP A 50129: Request for
Oral Proceedings 742
19.1.5 T 891/92, »Immunogenic peptides/MERCK*, EP A 218 531: Rejection of
Application on the Basis of New Arguments 742
XXXI
Contents
19.1.6 T 690/91, »Chymosin/CELLTECH«, EP A 68 691: Deviation From Ratio
Decidendi 743
19.1.7 T 1211/97, »Monoclonal antibodies/VELOS GROUP«, EP A1151128:
Reimbursement of AppealFee 744
19.1.8 T 1051/96, »Genetic linkages/PIONEER«, EP A 402 401: Scope of Claims in
Appeal 744
19.1.9 T 755/96, »Camptothecin derivatives/RESEARCH TRIANGLE INSTITUTE*,
EP A 418 099: Filing of New Claim Requests in Prosecution 745
19.1.10 T 1006/98, »DNA sequencing/HARVARD COLLEGE*, EP A 516 245:
Admissibility of Claims in Divisionals 745
19.1.11 T 280/99, »Tryptophan decarboxylase/CANADA«, EP A 425 597: New Ground for
Rejection of Application 746
19.1.12 T 610/01, »Plant growth/LONG ASHTON RESEARCH STATION«,
EP A703 983: Appeal on Behalf of the Wrong Party 746
19.1.13 T 715/01, »Glycosides/COGNIS«, EP A 646122: Grounds of Appeal Filed by the
Not Yet Registered Assignee of the Application 746
19.1.14 T 492/03, »Glycerine dehydrogenase/MAX PLANCK«, EP A 716 699: Refusal of
Application Based on a Surprising Ground Reimbursal of Appeal Fee 747
19.1.15 T 897/03, »Dermatophagoides allergens/IMMULOGIC PHARMACEUTICAL*,
EP A 623 168, and T 276/04, »Fibroblast growth factor/HUMAN GENOME
SCIENCES*, EP A 833 904: Improper Reasons for Refusal 747
19.1.16 T 1154/04, »Carrier material/INVITEK*, EP A 1278 834 748
19.2 Opposition Proceedings: Introduction of New Grounds 748
19.2.1 T 51/95, »Mature leukocyte interferons/HOFFMANN LA ROCHE«,
EP B1211148: New Ground of Opposition 748
19.2.2 T 736/95, »Fresh ground of opposition/AMGEN«, EP B1108 128 749
19.2.3 T 422/96, »Method for detecting an analyte/ENZO BIOCHEM«, EP B1212 670:
New Ground of Opposition 749
19.2.4 T 29/99, »Serine protease inhibitors/AMGEN«,EP B1205 475: Admissibility of
New Arguments at Oral Proceedings 750
19.2.5 T 620/99, »Homologous recombination/CELL GENESIS INC.«, EP B1452 484:
Ground for Opposition Raised by Others in Opposition Proceedings 750
19.2.6 T 279/00, »Asymmetric reduction process/AVECIA LTD.*, EP Bl 658211:
Imperfect Grounds for Appeal; New Ground for Opposition 750
19.2.7 T 1100/01, »Truncated transmembrane PACE/GENETICS*, EP B1 574 402:
Introduction of a New Ground For Opposition by the Opposition Division 751
19.3 Opposition Proceedings: The Filing of New Claim Requests 752
19.3.1 T 13/93, »Plant growth regulator/UNION OIL«, EP B1241 568: Admissibility of
Auxiliary Requests 752
19.3.2 T 339/93, »Recombinant vaccinia virus/HEALTH RESEARCH*, EP B1 83 286:
Admissibility of Auxiliary Requests 752
19.3.3 T 794/94, »Polypeptide expression/GENENTECH III*, EP Bl 1 929:
Admissibility of Auxiliary Requests 752
19.3.4 T 493/94, »CSF/CHUGAI«, EP Bl 169 566: Admissibility of Auxiliary Requests . 753
19.3.5 T 218/97, »t PA deletionmutants/GENENTECH*, EP Bl 365 597: Remittal to
First Instance , 754 .
19.3.6 T 160/99, »Chlamydia/WASHINGTON«, EP Bl 264 434: Admissibility of New
Claim Request in Oral Proceedings 754
19.3.7 T 1097/99, »HIV peptides/ADALTIS INC.«, EP Bl 326 490: Admissibility of New
Request in Oral Proceedings 755
19.3.8 T 189/01,»IFN p2/IL 6R/YEDARESEARCHANDDEyELOPMENTCO.,
LTD.*, EP Bl 413 908: Inadmissibility of Claims Submitted in Appeal Proceedings
That Are Broader Than Those Submitted With The Appeal 755
XXXII
Contents
19.3.9 T 882/01, »Protein expression system/CELLTECH«, EP B1 651 803: Strategy to
Delay Proceedings by Filing Claim Requests Late is an Abuse 756
19.3.10 T 796/02, »Hepatitis B antigen/GENENTECH«, EP B173 657: Abuse of Procedure
by Claim Request 756
19.3.11 T 454/03, »Viralvector/TRANSGENE«,EP Bl 742 834 756
19.3.12 T 15/01, »Mystery swine disease/SDLO«, EP B1 587 780 757
19.4 Opposition Proceedings: The Filing of New Documents/Experimental and Other
Evidence and the Submission of New Arguments 757
19.4.1 T 97/90, »Lubricants/TAKEMOTO YUSHI«, EP B1145 150: Late Submission in
Opposition Proceedings 757
19.4.2 T 342/98, »A. orizae/NOVOZYME, EP B1238 023: Late Submission of
Experimental Reports 758
19.4.3 T 785/97, »Support bound oligonucleotides/OXFORD GENE TECHNOLOGY
LIMITED*, EP B1 386 229: Late Filed Document Admitted 759
19.4.4 T 120/00, »Mycobacteria/COGENT«, EP B1460 041: Late Submission of
Experimental Report 759
19.4.5 T 397/02, »Endogenous gene expression/APPLIED RESEARCH SYS«,
EP B 505 500: Late Filed Documents and Experimental Evidence 759
19.4.6 T 340/00, »Thermostable enzyme/HOFFMANN La ROCHE«, EP B1395 736:
Prior Use/Prior Sales, Late Filed Evidence 760
19.5 Opposition Proceedings: Adaption of the Description 761
19.5.1 T 636/97, »Erythropoietin II/KIRIN AMGEN«, EP B1148 605: Adaption of
Description 761
19.6 Opposition Proceedings: Third Party Intervention 762
19.6.1 T 886/91, »HepatitisBvirus/BIOGEN«,EP Bl 13 828: Third Party Intervention . 762
19.6.2 T 296/93, »HBV antigen production/BIOGEN«, EP B1182 442: Third Party
Intervention 762
19.6.3 T 780/95, »Antigenic preparations/EVANS MEDICAL«, EP B1162 639: Third
Party Intervention 763
19.6.4 T 188/97, NANBV/Chiron Corporations EP B1318216: ThirdParty Intervention 763
19.6.5 T 694/01, »Testdevice/UNILEVER«,EP Bl 291194: Third Party Intervention . 764
19.6.6 T 103 8/00,»Apoptotic cells/NEXINS RESEARCH*, EP B 1 755 516: Intervention
After Abandoning Proceedings, Admissibility of Auxiliary Requests 765
19.7 Opposition Proceedings: Strawman 766
19.7.1 The Filing of an Opposition by a Strawman 766
19.8 Opposition Proceedings: Substantial Procedural Violation and Failures in the
Opposition Division's Decision 768
19.8.1 T 243/87, »Active dry yeast/LESAFFRE«, EP B 8 554: Invalid Decision 768
19.8.2 T 939/91, »Culture of Bifidobacteria/NESTLE«, EP B1192 986: Invalid Decision . 768
19.8.3 T 960/94, »Incorrectly composed division/SYNGENE«, EP B1135 587 768
19.8.4 T 594/00, »Antimicrobial susceptibility testing/ALAMAR«, EP B1 454 784:
Substantial Procedural Violation 769
19.8.5 T 900/02, »Bordetellapertussis toxin/SCLAVO S.p.A.«, EP B1 322 533: Partiality,
Different Opposition Division Decided on Adaptation of the Description; Three
Years and Seven Months to Issue Written Decision; Such Grave Procedural
Deficiencies Lead to Invalidation of the Decision of the Opposition Division 770
19.8.6 T 315/03, »Transgenic animals/HARVARD«, EP B1169 672 771
19.8.7 T 343/01, »Omega 3 highly unsaturated fatty acids/MARTEK«, EP B1 512 997. 771
19.8.8 T 654/04, »Phosphatidylserine/CHEMI«, EP B1 776 976 772
19.9 Opposition Proceedings: Miscellaneous 772
19.9.1 T 161/96, Underpayment of opposition fee/NOVO NORDISK«, EP B1 303 746:
Partial Payment of Opposition Fee 772
XXXIII
Contents
19.9.2 T 656/94, »Colony stimulating factor/KIRIN AMGEN«, EP B1237 545: Argu¬
ments of Others in Opposition Proceedings 772
19 9 3 G 3/99, »Admissibility of a joint opposition and appeal*, and T 272/95, »Relaxin/
HOWARD FLOREY INSTITUTE*, EP B1112149 773
19.9.4 G 1/97, »Request with a view to revision/ETA«, EP B1 98 239: Appeals Against
Decisions of Technical Boards 774
19.9.5 T 295/01, »Formalities officer duties/GLAXO«, EP B1 680 517, G 1/02, »Formal
ities officer's powers* • • • • 775
19.9.6 T 91/98, »Antiviral nucleosides/WELLCOME*, EP B1 306 597, and T 455/96,
»Blood substitute/BIOPURE CORPORATION*, EP B1277 289: Remittal to First
Instance 776
19.9.7 T 656/98, »Non partyappellant/GENENCOR«,EP Bl 260105: Transfer of patent
during appeal 776
19.9.8 T 224/99, »PDGF/ZYMOGENETICS«, EP B1177 957: Res Judicata 776
19.9.9 T 163/99, »Fatty acid esthers/UNILEVER*, EP B1383 404: Effect of Withdrawal of
All Claims 777
19.9.10 Tl 137/97, »Marek's Disease Virus Vaccine/AMERICAN HOME PRODUCTS
CORPORATION*, EP B1496135: Transfer of Opposition During Appeal, Late
Filed Document Admitted, Apportionment of Costs 777
19.9.11 T 8/01, »Chimeric chain receptors/CELL GENESYS*, EP B1 517 895:
Unsubstantiated Ground of Opposition 778
19.9.12 T 1126/00, »Platelet aggregationinhibitors/MILLENIUM«,EP Bl 477295: What
Happens if Both Patentee And Opponent Request Maintenance of a Patent in a
CertainForm? 779
19.9.13 T 475/01, »Phosphinotricine resistance gene/BAYER«, EP B1275 957: Procedural
Position of Non Professional Representatives and Substantiation of a Ground of
Appeal 779
19.9.14 T 716/01, »Bone resorption/WASHINGTON RESEARCH FOUNDATION*,
EP B1 502 928: Belated Withdrawal of Requests 780
19.9.15 T 1091/02, »Methods for detection/F. HOFFMANN LA ROCHE*, EP B1 520
794: Free Transfer of Opponent Status? 780
19.9.16 T 15/01, »Mystery swine disease/SDLO«, EP B1 587 780 780
20 Examples of Claims for a European Patent Application 781
21 Examples of Claims for a US Patent Application 783
21.1 Introduction 783
21.2 Claims Relating to Chemical Compounds 785
21.3 Claims Relating to DNA Sequences, Vectors, Plasmids, Host Cells, and Recombinant
DNAmolecules 785
21.4 Examples of Claims Relating to Polypeptides 787
21.5 Examples of Claims Relating to Microorganisms 787
21.6 Examples of Claims Relating to Monoclonal Antibodies 787
21.7 Examples of Claims Relating to Transgenic Plants and Animals 788
21.8 Method of Treatment Claims 789
21.9 Claims That Are Not Allowable In The U.S 790
22 Examples of Claims for a Japanese Patent Application 791
22.1 Introduction , 791
22.2 Claims Relating to Chemical Compounds 793
22.3 Claims Relating to DNA Sequences 793
22.4 Claims Relating to Recombinant Proteins 794
XXXIV
Contents
22.5 Claims Relating to Vectors and Transformants 796
22.6 Claims Relating to Microorganisms 796
22.7 Claims Relating to Monoclonal Antibodies 797
22.8 Claims Relating to Transgenic Plants 797
22.9 Claims Relating to Transgenic Animals 798
22.10 Claims Relating to Screening Methods 798
22.11 Claims Relating to Antagonists/Inhibitors or Agonists 798
22.12 Claims Relating to Pharmaceutical Inventions 799
23 How to Draft the Description of a European Patent Application 801
23.1 The Title of the Invention 801
23.2 The Indication of the Field of the Invention 801
23.3 The Acknowledgment of the Prior Art 801
23.4 The Technical Problem Underlying the Invention 801
23.5 The Solution 802
23.6 The Legends to the Figures 804
23.7 Examples 804
23.8 Sequence Listings 805
23.9 The Abstract 806
23.10 EASY 806
24 How to Draft the Description of a US Patent Application 809
24.1 The Elements of aU.S. Patent Application 809
24.1.1 Title of the Invention 809
24.1.2 Cross Reference to Related Applications 809
24.1.3 Background of the Invention 809
24.1.4 Summary of the Invention 810
24.1.5 Detailed Description of the Invention 810
24.1.6 Claims ¦ 813
24.1.7 Abstract 815
24.1.8 Sequence Listing 815
24.2 Meeting the Requirements of 35 U.S.C.§ 112, first paragraph 815
24.2.1 The Written Description Requirement 815
24.2.2 The Best Mode Requirement 819
25 How to Draft the Description of a Japanese Patent Application 823
25.1 Elements of a Japanese Patent Application 823
25.2 Title of the Invention 823
25.3 Technical Field 823
25.4 Prior Art 824
25.5 Problems to be Solved by the Invention 824
25.6 Means for Solving the Problems 824
25.7 Effects of the Invention 824
25.8 Mode for Carrying out the Invention 825
25.9 Examples 828
25.10 Sequence Listing 829
25.11 Abstract 829
26 How to Keep Notebooks for Successful Interferences 831
26.1 Record Keeping To Establish Dates Of Invention 831
26.2 Notebooks 832
XXXV
Contents
26.3 Electronic And Other Records Of Experiments 835
Decisions of the EPO 837
Decisions on U.S. Cases 855
Decisions on Japanese Cases 867
European Statutes 869
U.S. Statutes 871
Japanese Statutes 873
Index 875
XXXVI |
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| spelling | From clones to claims the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice by Hans-Rainer Jaenichen ... 4. ed. Köln ; München [u.a.] Heymann 2006 XXXVI, 881 S. txt rdacontent n rdamedia nc rdacarrier Heymanns intellectual property European Patent Office Europäisches Patentamt (DE-588)1052705-9 gnd rswk-swf Recht Biotechnology Law and legislation Japan Digests Biotechnology Law and legislation United States Digests Biotechnology Europe Patents Digests Biotechnologie (DE-588)4069491-4 gnd rswk-swf Europa USA 1\p (DE-588)4152408-1 Entscheidungssammlung gnd-content Europäisches Patentamt (DE-588)1052705-9 b Biotechnologie (DE-588)4069491-4 s 2\p DE-604 Jaenichen, Hans-Rainer Sonstige (DE-588)1030592500 oth HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014681233&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk 2\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | From clones to claims the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice European Patent Office Europäisches Patentamt (DE-588)1052705-9 gnd Recht Biotechnology Law and legislation Japan Digests Biotechnology Law and legislation United States Digests Biotechnology Europe Patents Digests Biotechnologie (DE-588)4069491-4 gnd |
| subject_GND | (DE-588)1052705-9 (DE-588)4069491-4 (DE-588)4152408-1 |
| title | From clones to claims the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice |
| title_auth | From clones to claims the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice |
| title_exact_search | From clones to claims the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice |
| title_exact_search_txtP | From clones to claims the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice |
| title_full | From clones to claims the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice by Hans-Rainer Jaenichen ... |
| title_fullStr | From clones to claims the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice by Hans-Rainer Jaenichen ... |
| title_full_unstemmed | From clones to claims the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice by Hans-Rainer Jaenichen ... |
| title_short | From clones to claims |
| title_sort | from clones to claims the european patent office s case law on the patentability of biotechnology inventions in comparison to the united states and japanese practice |
| title_sub | the European Patent Office's case law on the patentability of biotechnology inventions in comparison to the United States and Japanese practice |
| topic | European Patent Office Europäisches Patentamt (DE-588)1052705-9 gnd Recht Biotechnology Law and legislation Japan Digests Biotechnology Law and legislation United States Digests Biotechnology Europe Patents Digests Biotechnologie (DE-588)4069491-4 gnd |
| topic_facet | European Patent Office Europäisches Patentamt Recht Biotechnology Law and legislation Japan Digests Biotechnology Law and legislation United States Digests Biotechnology Europe Patents Digests Biotechnologie Europa USA Entscheidungssammlung |
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